- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565851
Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865)
Study Overview
Status
Conditions
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Seromucinous Carcinoma
- Ovarian Undifferentiated Carcinoma
- Ovarian Clear Cell Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Mucinous Adenocarcinoma
- Ovarian Transitional Cell Carcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Fallopian Tube Serous Adenocarcinoma
- Fallopian Tube Undifferentiated Carcinoma
- Ovarian Serous Adenocarcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Primary Peritoneal Clear Cell Adenocarcinoma
- Primary Peritoneal Transitional Cell Carcinoma
- Primary Peritoneal Undifferentiated Carcinoma
- Primary Peritoneal Endometrioid Adenocarcinoma
- Ovarian Brenner Tumor
- Ovarian Clear Cell Adenocarcinofibroma
- Clear Cell Adenocarcinoma
- Undifferentiated Carcinoma
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases the duration of overall survival in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.
II. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.
SECONDARY OBJECTIVES:
I. To determine if the addition of bevacizumab to the second-line and maintenance phase of treatment increases the duration of progression-free survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.
II. To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity in these patients undergoing retreatment with both agents as first recurrence therapy.
III. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases quality of life (QOL) in patients with recurrent platinum-sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer, as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) trial outcome index and Rand Short Form (SF)-36 physical functioning scale.
IV. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum-sensitive epithelial ovarian, peritoneal primary or fallopian tube cancer.
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To define molecular and biochemical profiles associated with the duration of progression-free survival in platinum-sensitive recurrent ovarian, peritoneal primary or fallopian tube carcinoma treated with combination chemotherapy with or without bevacizumab followed with or without maintenance bevacizumab therapy in the presence or absence of secondary surgical cytoreduction.
II. To identify molecular determinants that predict sensitivity or resistance to carboplatin and paclitaxel with or without bevacizumab followed with or without maintenance bevacizumab therapy.
III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.
OUTLINE: Patients are assigned to 1 of 4 treatment groups. Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking) are eligible to receive chemotherapy after randomization.
Patients who are eligible for surgery undergo abdominal exploration with cytoreduction. Patients are then randomized to 1 of 4 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or docetaxel IV over 1 hour and carboplatin IV over 60 minutes on day 1.
ARM II: Patients receive chemotherapy as in Arm I and bevacizumab IV over 30-90 minutes on day 1.
ARM III: Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
ARM IV: Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.
In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of therapy. Patients with stable disease or partial regression receive a maximum of 8 courses.
Patients without measurable lesions as determined by a computed tomography (CT) scan prior to initiating study treatment continue therapy for 6 courses or, if cancer antigen (CA)-125 normalizes, for 2 courses beyond CA-125 normalization, whichever is greater. Patients in Arm II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Hiroshima City, Japan, 734-8551
- Hiroshima University Hospital
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Matsuyama, Japan, 791-0280
- Shikoku Cancer Center
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Minami-ku, Japan, 811 1395
- National Kyushu Cancer Center
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Minato-ku, Tokyo, Japan, 105-8461
- Jikei University School of Medicine
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Osaka, Japan, 589 8511
- Kindai University
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Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
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Tokyo, Japan, 104 0045
- National Cancer Center Hospital
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Tottori, Japan, 680-8550
- Tottori University
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Aoba-ku
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Sendai, Aoba-ku, Japan, 980-8574
- Tohoku University School of Medicine
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Hiroshima
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Kure, Hiroshima, Japan, 737
- Kure National Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Iwate
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Shiwa-gun, Iwate, Japan, 028-3695
- Iwate Medical University Hospital
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Kagoshima
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Kagoshima City, Kagoshima, Japan, 890-8760
- Kagoshima City Hospital
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Niigata
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Niigata City, Niigata, Japan, 951-8520
- Niigata University Medical And Dental Hospital
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Suntou
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Shizuoka City, Suntou, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Keio University
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Incheon, Korea, Republic of, 405-760
- Gachon University Gil Hospital
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 134-727
- Kyung Hee University Hospital at Gangdong
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Seoul, Korea, Republic of, 06273
- Gangnam Severance Hospital
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Seoul, Korea, Republic of, 139-706
- Korea Cancer Center Hospital
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Seoul, Korea, Republic of, 158-710
- Ewha Woman's University
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Suwon, Korea, Republic of, 443-721
- Ajou University Hospital
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Daegu
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Dalseo-gu, Daegu, Korea, Republic of, 42601
- Keimyung University-Dongsan Medical Center
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- National Cancer Center-Korea
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Korea
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Seoul, Korea, Korea, Republic of, 135-710
- Samsung Medical Center
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Seoul, Korea, Korea, Republic of, 137-040
- Catholic University of Korea-Seoul Saint Mary's Hospital
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Kyeonggi-do
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Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Alaska
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Anchorage, Alaska, United States, 98508
- Anchorage Associates in Radiation Medicine
-
Anchorage, Alaska, United States, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, United States, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, United States, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, United States, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, United States, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
-
Anchorage, Alaska, United States, 99504
- Anchorage Radiation Therapy Center
-
Anchorage, Alaska, United States, 99508
- Alaska Regional Hospital
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Arkansas
-
Hot Springs, Arkansas, United States, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
-
Auburn, California, United States, 95602
- Sutter Auburn Faith Hospital
-
Auburn, California, United States, 95603
- Sutter Cancer Centers Radiation Oncology Services-Auburn
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Berkeley, California, United States, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
-
Burlingame, California, United States, 94010
- Mills-Peninsula Medical Center
-
Cameron Park, California, United States, 95682
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
-
Concord, California, United States, 94520
- John Muir Medical Center-Concord Campus
-
Davis, California, United States, 95616
- Sutter Davis Hospital
-
La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
-
Long Beach, California, United States, 90806
- Long Beach Memorial Medical Center-Todd Cancer Institute
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
Los Angeles, California, United States, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Modesto, California, United States, 95355
- Memorial Medical Center
-
Mountain View, California, United States, 94040
- Palo Alto Medical Foundation-Camino Division
-
Mountain View, California, United States, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
-
Novato, California, United States, 94945
- Sutter Cancer Research Consortium
-
Orange, California, United States, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Palo Alto, California, United States, 94304
- Stanford Cancer Institute Palo Alto
-
Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Health Care
-
Roseville, California, United States, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
-
Roseville, California, United States, 95661
- Sutter Roseville Medical Center
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Sacramento, California, United States, 95816
- Sutter Medical Center Sacramento
-
San Francisco, California, United States, 94115
- California Pacific Medical Center-Pacific Campus
-
San Francisco, California, United States, 94115
- UCSF Medical Center-Mount Zion
-
Santa Cruz, California, United States, 95065
- Palo Alto Medical Foundation-Santa Cruz
-
Santa Rosa, California, United States, 95403
- Sutter Pacific Medical Foundation
-
Sunnyvale, California, United States, 94086
- Palo Alto Medical Foundation-Sunnyvale
-
Vacaville, California, United States, 95687
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
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Vallejo, California, United States, 94589
- Sutter Solano Medical Center/Cancer Center
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Walnut Creek, California, United States, 94598
- John Muir Medical Center-Walnut Creek
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
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Boulder, Colorado, United States, 80301
- Boulder Community Hospital
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Boulder, Colorado, United States, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, United States, 80210
- Porter Adventist Hospital
-
Denver, Colorado, United States, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, United States, 80218
- SCL Health Saint Joseph Hospital
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Denver, Colorado, United States, 80220
- Rose Medical Center
-
Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers-Rose
-
Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, United States, 80222
- Western States Cancer Research NCORP
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Durango, Colorado, United States, 81301
- Mercy Medical Center
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Durango, Colorado, United States, 81301
- Southwest Oncology PC
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Englewood, Colorado, United States, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, United States, 80113
- Swedish Medical Center
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Englewood, Colorado, United States, 80110
- Rocky Mountain Gynecologic Oncology PC
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Golden, Colorado, United States, 80401
- Mountain Blue Cancer Care Center
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Grand Junction, Colorado, United States, 81501
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, United States, 80631
- North Colorado Medical Center
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Greenwood Village, Colorado, United States, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
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Lakewood, Colorado, United States, 80228
- Saint Anthony Hospital
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Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Centers-Littleton
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Littleton, Colorado, United States, 80122
- Littleton Adventist Hospital
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Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, United States, 80501
- Longmont United Hospital
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Longmont, Colorado, United States, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, United States, 80539
- McKee Medical Center
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Parker, Colorado, United States, 80138
- Parker Adventist Hospital
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Parker, Colorado, United States, 80138
- Rocky Mountain Cancer Centers-Parker
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Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, United States, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers-Thornton
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Thornton, Colorado, United States, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, United States, 80033
- SCL Health Lutheran Medical Center
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- Hartford HealthCare - Saint Vincent's Medical Center
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Farmington, Connecticut, United States, 06030
- University of Connecticut
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Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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Middletown, Connecticut, United States, 06457
- Middlesex Hospital
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New Britain, Connecticut, United States, 06050
- The Hospital of Central Connecticut
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Delaware
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Lewes, Delaware, United States, 19958
- Beebe Medical Center
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Newark, Delaware, United States, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, United States, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, United States, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, United States, 19718
- Christiana Care Health System-Christiana Hospital
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Newark, Delaware, United States, 19713
- Christiana Gynecologic Oncology LLC
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Rehoboth Beach, Delaware, United States, 19971
- Beebe Health Campus
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Seaford, Delaware, United States, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, United States, 19801
- Christiana Care Health System-Wilmington Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Florida
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Altamonte Springs, Florida, United States, 32701
- AdventHealth Altamonte
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Fort Myers, Florida, United States, 33905
- Florida Gynecologic Oncology
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Kissimmee, Florida, United States, 34744
- AdventHealth Kissimmee
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Orlando, Florida, United States, 32803
- AdventHealth Orlando
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Orlando, Florida, United States, 32803
- AdventHealth Medical Group Urology at Orlando
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Orlando, Florida, United States, 32822
- AdventHealth East Orlando
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Saint Petersburg, Florida, United States, 33713
- Women's Cancer Associates
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Winter Park, Florida, United States, 32792
- AdventHealth Winter Park
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Georgia
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Augusta, Georgia, United States, 30912
- Augusta University Medical Center
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Columbus, Georgia, United States, 31904
- John B Amos Cancer Center
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Decatur, Georgia, United States, 30033
- Dekalb Medical Center
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center-Gainesville
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Savannah, Georgia, United States, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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Savannah, Georgia, United States, 31404
- Summit Cancer Care-Memorial
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Savannah, Georgia, United States, 31404
- Low Country Cancer Care
-
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, United States, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, United States, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Emmett, Idaho, United States, 83617
- Walter Knox Memorial Hospital
-
Fruitland, Idaho, United States, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, United States, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, United States, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, United States, 83686
- Saint Luke's Cancer Institute - Nampa
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Nampa, Idaho, United States, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Twin Falls, Idaho, United States, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Northwest Community Hospital
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Aurora, Illinois, United States, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, United States, 61704
- Illinois CancerCare-Bloomington
-
Bloomington, Illinois, United States, 61701
- Saint Joseph Medical Center
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Canton, Illinois, United States, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, United States, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, United States, 62918
- SIH Cancer Institute
-
Carthage, Illinois, United States, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, United States, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
-
Chicago, Illinois, United States, 60612
- University of Illinois
-
Danville, Illinois, United States, 61832
- Carle on Vermilion
-
Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, United States, 62401
- Carle Physician Group-Effingham
-
Eureka, Illinois, United States, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, United States, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, United States, 61401
- Illinois CancerCare-Galesburg
-
Geneva, Illinois, United States, 60134
- Northwestern Medicine Cancer Center Delnor
-
Hinsdale, Illinois, United States, 60521
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
-
Joliet, Illinois, United States, 60435
- Duly Health and Care Joliet
-
Kewanee, Illinois, United States, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, United States, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, United States, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, United States, 62864
- Good Samaritan Regional Health Center
-
New Lenox, Illinois, United States, 60451
- UC Comprehensive Cancer Center at Silver Cross
-
O'Fallon, Illinois, United States, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, United States, 61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa, Illinois, United States, 61350
- Radiation Oncology of Northern Illinois
-
Pekin, Illinois, United States, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, United States, 61554
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, United States, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, United States, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, United States, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, United States, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, United States, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, United States, 62781
- Memorial Medical Center
-
Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, United States, 62702
- Springfield Clinic
-
Springfield, Illinois, United States, 62702
- Central Illinois Hematology Oncology Center
-
Swansea, Illinois, United States, 62226
- Southwest Illinois Health Services LLP
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center
-
Urbana, Illinois, United States, 61801
- The Carle Foundation Hospital
-
Warrenville, Illinois, United States, 60555
- Northwestern Medicine Cancer Center Warrenville
-
Yorkville, Illinois, United States, 60560
- Rush-Copley Healthcare Center
-
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Indiana
-
Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
-
Elkhart, Indiana, United States, 46514
- Michiana Hematology Oncology PC-Elkhart
-
Elkhart, Indiana, United States, 46514-2098
- Elkhart Clinic
-
Indianapolis, Indiana, United States, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
Indianapolis, Indiana, United States, 46260
- Ascension Saint Vincent Indianapolis Hospital
-
Kokomo, Indiana, United States, 46904
- Community Howard Regional Health
-
La Porte, Indiana, United States, 46350
- IU Health La Porte Hospital
-
Michigan City, Indiana, United States, 46360
- Franciscan Saint Anthony Health-Michigan City
-
Michigan City, Indiana, United States, 46360
- Woodland Cancer Care Center
-
Mishawaka, Indiana, United States, 46545
- Michiana Hematology Oncology PC-Mishawaka
-
Mishawaka, Indiana, United States, 46545
- Saint Joseph Regional Medical Center-Mishawaka
-
Munster, Indiana, United States, 46321
- The Community Hospital
-
Plymouth, Indiana, United States, 46563
- Michiana Hematology Oncology PC-Plymouth
-
Richmond, Indiana, United States, 47374
- Reid Health
-
South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, United States, 46601
- Michiana Hematology Oncology PC-South Bend
-
South Bend, Indiana, United States, 46628
- Northern Indiana Cancer Research Consortium
-
South Bend, Indiana, United States, 46617
- South Bend Clinic
-
Westville, Indiana, United States, 46391
- Michiana Hematology Oncology PC-Westville
-
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Iowa
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Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Council Bluffs, Iowa, United States, 51503
- Alegent Health Mercy Hospital
-
Creston, Iowa, United States, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, United States, 50314
- Mission Cancer and Blood - Laurel
-
Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50309
- Iowa-Wide Oncology Research Coalition NCORP
-
Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
Spencer, Iowa, United States, 51301
- Abben Cancer Center
-
West Des Moines, Iowa, United States, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
-
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Kansas
-
Chanute, Kansas, United States, 66720
- Cancer Center of Kansas - Chanute
-
Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
-
Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
-
Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
-
Kansas City, Kansas, United States, 66112
- Providence Medical Center
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas-Kingman
-
Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
-
Lenexa, Kansas, United States, 66219
- Kansas Institute of Medicine Cancer and Blood Center
-
Lenexa, Kansas, United States, 66219
- Minimally Invasive Surgery Hospital
-
Liberal, Kansas, United States, 67905
- Cancer Center of Kansas-Liberal
-
Manhattan, Kansas, United States, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, United States, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, United States, 67114
- Cancer Center of Kansas - Newton
-
Overland Park, Kansas, United States, 66209
- Menorah Medical Center
-
Overland Park, Kansas, United States, 66213
- Saint Luke's South Hospital
-
Parsons, Kansas, United States, 67357
- Cancer Center of Kansas - Parsons
-
Prairie Village, Kansas, United States, 66208
- Kansas City NCI Community Oncology Research Program
-
Pratt, Kansas, United States, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, United States, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, United States, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, United States, 67208
- Associates In Womens Health
-
Wichita, Kansas, United States, 67214
- Wichita NCI Community Oncology Research Program
-
Wichita, Kansas, United States, 67214
- Wesley Medical Center
-
Winfield, Kansas, United States, 67156
- Cancer Center of Kansas - Winfield
-
-
Kentucky
-
Bardstown, Kentucky, United States, 40004
- Flaget Memorial Hospital
-
Corbin, Kentucky, United States, 40701
- Commonwealth Cancer Center-Corbin
-
Crestview Hills, Kentucky, United States, 41017
- Oncology Hematology Care Inc-Crestview
-
Lexington, Kentucky, United States, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, United States, 40509
- Saint Joseph Hospital East
-
Louisville, Kentucky, United States, 40202
- The James Graham Brown Cancer Center at University of Louisville
-
Louisville, Kentucky, United States, 40202
- Jewish Hospital
-
Louisville, Kentucky, United States, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, United States, 40215
- Saints Mary and Elizabeth Hospital
-
Shepherdsville, Kentucky, United States, 40165
- Jewish Hospital Medical Center South
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70806
- Baton Rouge General Medical Center
-
Baton Rouge, Louisiana, United States, 70809
- Hematology/Oncology Clinic PLLC
-
Baton Rouge, Louisiana, United States, 70817
- Woman's Hospital
-
Marrero, Louisiana, United States, 70072
- West Jefferson Medical Center
-
New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
-
Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center
-
Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
-
Elkton, Maryland, United States, 21921
- Christiana Care - Union Hospital
-
Randallstown, Maryland, United States, 21133
- Northwest Hospital Center
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center - University Campus
-
Worcester, Massachusetts, United States, 01605
- UMass Memorial Medical Center - Memorial Division
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- Saint Joseph Mercy Hospital
-
Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium NCORP
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Big Rapids, Michigan, United States, 49307
- Spectrum Health Big Rapids Hospital
-
Brighton, Michigan, United States, 48114
- Saint Joseph Mercy Brighton
-
Brighton, Michigan, United States, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brownstown, Michigan, United States, 48183
- Henry Ford Cancer Institute-Downriver
-
Canton, Michigan, United States, 48188
- Saint Joseph Mercy Canton
-
Canton, Michigan, United States, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Caro, Michigan, United States, 48723
- Caro Cancer Center
-
Chelsea, Michigan, United States, 48118
- Saint Joseph Mercy Chelsea
-
Chelsea, Michigan, United States, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Clarkston, Michigan, United States, 48346
- Hematology Oncology Consultants-Clarkston
-
Clarkston, Michigan, United States, 48346
- Newland Medical Associates-Clarkston
-
Clinton Township, Michigan, United States, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn, Michigan, United States, 48124
- Beaumont Hospital - Dearborn
-
Dearborn, Michigan, United States, 48126
- Henry Ford Medical Center-Fairlane
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48236
- Ascension Saint John Hospital
-
East China Township, Michigan, United States, 48054
- Great Lakes Cancer Management Specialists-Doctors Park
-
Escanaba, Michigan, United States, 49829
- Green Bay Oncology - Escanaba
-
Farmington Hills, Michigan, United States, 48334
- Weisberg Cancer Treatment Center
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesee Cancer and Blood Disease Treatment Center
-
Flint, Michigan, United States, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
-
Grand Blanc, Michigan, United States, 48439
- Genesys Regional Medical Center
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
-
Grand Rapids, Michigan, United States, 49503
- Cancer Research Consortium of West Michigan NCORP
-
Grand Rapids, Michigan, United States, 49503
- Trinity Health Grand Rapids Hospital
-
Grosse Pointe Woods, Michigan, United States, 48236
- Academic Hematology Oncology Specialists
-
Grosse Pointe Woods, Michigan, United States, 48236
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
-
Grosse Pointe Woods, Michigan, United States, 48236
- Michigan Breast Specialists-Grosse Pointe Woods
-
Iron Mountain, Michigan, United States, 49801
- Green Bay Oncology - Iron Mountain
-
Jackson, Michigan, United States, 49201
- Allegiance Health
-
Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, United States, 49048
- Borgess Medical Center
-
Lansing, Michigan, United States, 48912
- Sparrow Hospital
-
Livonia, Michigan, United States, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Livonia, Michigan, United States, 48154
- Hope Cancer Clinic
-
Macomb, Michigan, United States, 48044
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
-
Macomb, Michigan, United States, 48044
- Michigan Breast Specialists-Macomb Township
-
Marlette, Michigan, United States, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Muskegon, Michigan, United States, 49442
- Mercy Health Partners-Hackley Campus
-
Muskegon, Michigan, United States, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, United States, 49120
- Lakeland Hospital Niles
-
Novi, Michigan, United States, 48377
- Henry Ford Medical Center-Columbus
-
Petoskey, Michigan, United States, 49770
- McLaren Cancer Institute-Northern Michigan
-
Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
-
Pontiac, Michigan, United States, 48341
- 21st Century Oncology-Pontiac
-
Pontiac, Michigan, United States, 48341
- Hope Cancer Center
-
Pontiac, Michigan, United States, 48341
- Newland Medical Associates-Pontiac
-
Port Huron, Michigan, United States, 48060
- Lake Huron Medical Center
-
Reed City, Michigan, United States, 49677
- Spectrum Health Reed City Hospital
-
Rochester Hills, Michigan, United States, 48309
- Great Lakes Cancer Management Specialists-Rochester Hills
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital-Royal Oak
-
Saginaw, Michigan, United States, 48601
- Ascension Saint Mary's Hospital
-
Saginaw, Michigan, United States, 48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Saint Joseph, Michigan, United States, 49085
- Lakeland Medical Center Saint Joseph
-
Saint Joseph, Michigan, United States, 49085
- Marie Yeager Cancer Center
-
Sterling Heights, Michigan, United States, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Traverse City, Michigan, United States, 49684
- Munson Medical Center
-
Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
-
Warren, Michigan, United States, 48088
- Advanced Breast Care Center PLLC
-
Warren, Michigan, United States, 48093
- Great Lakes Cancer Management Specialists-Macomb Professional Building
-
Warren, Michigan, United States, 48093
- Macomb Hematology Oncology PC
-
Warren, Michigan, United States, 48093
- Michigan Breast Specialists-Warren
-
West Bloomfield, Michigan, United States, 48322
- Henry Ford West Bloomfield Hospital
-
West Branch, Michigan, United States, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Wyoming, Michigan, United States, 49519
- Metro Health Hospital
-
Ypsilanti, Michigan, United States, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, United States, 48106
- Huron Gastroenterology PC
-
-
Minnesota
-
Bemidji, Minnesota, United States, 56601
- Sanford Joe Lueken Cancer Center
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
-
Duluth, Minnesota, United States, 55805
- Saint Luke's Hospital of Duluth
-
Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, United States, 55432
- Unity Hospital
-
Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
-
Maple Grove, Minnesota, United States, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55454
- Health Partners Inc
-
New Ulm, Minnesota, United States, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, United States, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, United States, 55101
- Regions Hospital
-
Saint Paul, Minnesota, United States, 55102
- United Hospital
-
Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, United States, 55082
- Lakeview Hospital
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, United States, 55092
- Fairview Lakes Medical Center
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
-
Jackson, Mississippi, United States, 39216
- Saint Dominic-Jackson Memorial Hospital
-
Pascagoula, Mississippi, United States, 39581
- Singing River Hospital
-
-
Missouri
-
Bolivar, Missouri, United States, 65613
- Central Care Cancer Center - Bolivar
-
Bonne Terre, Missouri, United States, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, United States, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, United States, 63703
- Southeast Cancer Center
-
Columbia, Missouri, United States, 65212
- University of Missouri - Ellis Fischel
-
Independence, Missouri, United States, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, United States, 65109
- Capital Region Southwest Campus
-
Joplin, Missouri, United States, 64804
- Freeman Health System
-
Joplin, Missouri, United States, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, United States, 64132
- Research Medical Center
-
Kansas City, Missouri, United States, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Lee's Summit, Missouri, United States, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, United States, 64068
- Liberty Radiation Oncology Center
-
Rolla, Missouri, United States, 65401
- Delbert Day Cancer Institute at PCRMC
-
Rolla, Missouri, United States, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
Saint Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
-
Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
-
Saint Louis, Missouri, United States, 63109
- Saint Louis Cancer and Breast Institute-South City
-
Saint Louis, Missouri, United States, 63104
- SSM Health Saint Louis University Hospital
-
Sainte Genevieve, Missouri, United States, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP
-
Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
-
Sullivan, Missouri, United States, 63080
- Missouri Baptist Sullivan Hospital
-
Sunset Hills, Missouri, United States, 63127
- Missouri Baptist Outpatient Center-Sunset Hills
-
-
Montana
-
Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- CHI Health Saint Francis
-
Kearney, Nebraska, United States, 68847
- CHI Health Good Samaritan
-
Kearney, Nebraska, United States, 68845
- Heartland Hematology and Oncology
-
Lincoln, Nebraska, United States, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, United States, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, United States, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, United States, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
-
Omaha, Nebraska, United States, 68122
- Hematology and Oncology Consultants PC
-
Papillion, Nebraska, United States, 68046
- Midlands Community Hospital
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Women's Cancer Center of Nevada
-
Reno, Nevada, United States, 89502
- Renown Regional Medical Center
-
Reno, Nevada, United States, 89502
- Center of Hope at Renown Medical Center
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Cooper Hospital University Medical Center
-
Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
-
Hamilton, New Jersey, United States, 08690
- The Cancer Institute of New Jersey Hamilton
-
Morristown, New Jersey, United States, 07960
- Morristown Medical Center
-
Mount Holly, New Jersey, United States, 08060
- Virtua Memorial
-
Neptune, New Jersey, United States, 07753
- Jersey Shore Medical Center
-
New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
-
Phillipsburg, New Jersey, United States, 08865
- Saint Luke's Hospital-Warren Campus
-
Summit, New Jersey, United States, 07902
- Overlook Hospital
-
Voorhees, New Jersey, United States, 08043
- Virtua Voorhees
-
Voorhees, New Jersey, United States, 08043
- MD Anderson Cancer Center at Cooper-Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, United States, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Las Cruces, New Mexico, United States, 88011
- Memorial Medical Center - Las Cruces
-
-
New York
-
Albany, New York, United States, 12208
- Women's Cancer Care Associates LLC
-
Brightwaters, New York, United States, 11718
- Island Gynecologic Oncology
-
Brooklyn, New York, United States, 11215
- New York-Presbyterian/Brooklyn Methodist Hospital
-
Brooklyn, New York, United States, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
Lake Success, New York, United States, 11042
- Northwell Health/Center for Advanced Medicine
-
Manhasset, New York, United States, 11030
- North Shore University Hospital
-
New Hyde Park, New York, United States, 11040
- Long Island Jewish Medical Center
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
New York, New York, United States, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, United States, 14642
- University of Rochester
-
Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
-
-
North Carolina
-
Asheboro, North Carolina, United States, 27203
- Randolph Hospital
-
Asheville, North Carolina, United States, 28803
- AdventHealth Infusion Center Asheville
-
Burlington, North Carolina, United States, 27215
- Cone Health Cancer Center at Alamance Regional
-
Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
-
Charlotte, North Carolina, United States, 28207
- Oncology Specialists of Charlotte
-
Charlotte, North Carolina, United States, 28262
- Southern Oncology Specialists-Charlotte
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Greensboro, North Carolina, United States, 27403
- Cone Health Cancer Center
-
Hendersonville, North Carolina, United States, 28792
- AdventHealth Hendersonville
-
Huntersville, North Carolina, United States, 28078
- Novant Health Cancer Institute - Huntersville
-
Huntersville, North Carolina, United States, 28078
- Southern Oncology Specialists-Huntersville
-
Matthews, North Carolina, United States, 28105
- Matthews Radiation Oncology Center
-
Matthews, North Carolina, United States, 28105
- Novant Health Cancer Institute - Matthews
-
Mebane, North Carolina, United States, 27302
- Cone Heath Cancer Center at Mebane
-
Mooresville, North Carolina, United States, 28117
- Novant Health Cancer Institute - Mooresville
-
Pinehurst, North Carolina, United States, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh, North Carolina, United States, 27609
- Duke Raleigh Hospital
-
Reidsville, North Carolina, United States, 27320
- Annie Penn Memorial Hospital
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research Consortium NCORP
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, United States, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, United States, 58122
- Sanford Broadway Medical Center
-
Fargo, North Dakota, United States, 58122
- Sanford Clinic North-Fargo
-
-
Ohio
-
Akron, Ohio, United States, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, United States, 44304
- Summa Health System - Akron Campus
-
Belpre, Ohio, United States, 45714
- Strecker Cancer Center-Belpre
-
Canton, Ohio, United States, 44710
- Aultman Health Foundation
-
Centerville, Ohio, United States, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, United States, 45459
- Dayton Physicians LLC-Miami Valley South
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, United States, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, United States, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, United States, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, United States, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, United States, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, United States, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati, Ohio, United States, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, United States, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, United States, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, United States, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, United States, 43228
- Doctors Hospital
-
Columbus, Ohio, United States, 43213
- Mount Carmel East Hospital
-
Columbus, Ohio, United States, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, United States, 43215
- Columbus NCI Community Oncology Research Program
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Dayton Physician LLC-Miami Valley Hospital North
-
Dayton, Ohio, United States, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45459
- Dayton NCI Community Oncology Research Program
-
Delaware, Ohio, United States, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, United States, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Fairfield, Ohio, United States, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, United States, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, United States, 45840
- Orion Cancer Care
-
Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, United States, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, United States, 45331
- Wayne Hospital
-
Greenville, Ohio, United States, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, United States, 45429
- Kettering Medical Center
-
Kettering, Ohio, United States, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, United States, 45420
- First Dayton Cancer Care
-
Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
-
Lancaster, Ohio, United States, 43130
- Lancaster Radiation Oncology
-
Mansfield, Ohio, United States, 44903
- OhioHealth Mansfield Hospital
-
Marietta, Ohio, United States, 45750
- Marietta Memorial Hospital
-
Marion, Ohio, United States, 43302
- OhioHealth Marion General Hospital
-
Mayfield Heights, Ohio, United States, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, United States, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Middletown, Ohio, United States, 45042
- Dayton Physicians LLC-Signal Point
-
Mount Vernon, Ohio, United States, 43050
- Knox Community Hospital
-
Newark, Ohio, United States, 43055
- Licking Memorial Hospital
-
Newark, Ohio, United States, 43055
- Newark Radiation Oncology
-
Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
-
Sidney, Ohio, United States, 45365
- Dayton Physicians LLC-Wilson
-
Springfield, Ohio, United States, 45505
- Springfield Regional Medical Center
-
Springfield, Ohio, United States, 45504
- Springfield Regional Cancer Center
-
Troy, Ohio, United States, 45373
- Upper Valley Medical Center
-
Troy, Ohio, United States, 45373
- Dayton Physicians LLC - Troy
-
Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
-
Wright-Patterson Air Force Base, Ohio, United States, 45433
- Wright-Patterson Medical Center
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, United States, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
-
Tulsa, Oklahoma, United States, 74146
- Warren Clinic Oncology-Tulsa
-
Tulsa, Oklahoma, United States, 74136
- Warren Clinic-Tulsa South
-
-
Oregon
-
Baker City, Oregon, United States, 97814
- Saint Alphonsus Medical Center-Baker City
-
Bend, Oregon, United States, 97701
- Saint Charles Health System
-
Clackamas, Oregon, United States, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, United States, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, United States, 97420
- Bay Area Hospital
-
Milwaukie, Oregon, United States, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, United States, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, United States, 97914
- Saint Alphonsus Medical Center-Ontario
-
Oregon City, Oregon, United States, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
Portland, Oregon, United States, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Portland, Oregon, United States, 97213
- Providence Portland Medical Center
-
Portland, Oregon, United States, 97225
- Providence Saint Vincent Medical Center
-
Portland, Oregon, United States, 97227
- Compass Oncology Rose Quarter
-
-
Pennsylvania
-
Abington, Pennsylvania, United States, 19001
- Jefferson Abington Hospital
-
Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, United States, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Bethlehem, Pennsylvania, United States, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
Hazleton, Pennsylvania, United States, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hershey, Pennsylvania, United States, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Kittanning, Pennsylvania, United States, 16201
- Armstrong Center for Medicine and Health
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
-
Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, United States, 15224
- West Penn Hospital
-
Scranton, Pennsylvania, United States, 18510
- Community Medical Center
-
State College, Pennsylvania, United States, 16801
- Geisinger Medical Group
-
West Reading, Pennsylvania, United States, 19611
- Reading Hospital
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
-
Rapid City, South Dakota, United States, 57701
- Black Hills Obstetrics and Gynecology
-
Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, United States, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Bristol, Tennessee, United States, 37620
- Wellmont Medical Associates Oncology and Hematology-Bristol
-
Bristol, Tennessee, United States, 37620
- Bristol Regional Medical Center
-
Chattanooga, Tennessee, United States, 37404
- Memorial Hospital
-
Hixson, Tennessee, United States, 37343
- Pulmonary Medicine Center of Chattanooga-Hixson
-
Johnson City, Tennessee, United States, 37604
- Wellmont Medical Associates Oncology and Hematology-Johnson City
-
Kingsport, Tennessee, United States, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, United States, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Ooltewah, Tennessee, United States, 37363
- Memorial GYN Plus
-
-
Texas
-
Amarillo, Texas, United States, 79106
- The Don and Sybil Harrington Cancer Center
-
Amarillo, Texas, United States, 79106
- Texas Tech University Health Sciences Center-Amarillo
-
Austin, Texas, United States, 78701
- Dell Seton Medical Center at The University of Texas
-
Bryan, Texas, United States, 77802
- Saint Joseph Regional Cancer Center
-
Conroe, Texas, United States, 77384
- MD Anderson in The Woodlands
-
Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Galveston, Texas, United States, 77555-0565
- University of Texas Medical Branch
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Houston, Texas, United States, 77026-1967
- Lyndon Baines Johnson General Hospital
-
Houston, Texas, United States, 77030
- Houston Methodist Hospital
-
Houston, Texas, United States, 77030
- Memorial Hermann Texas Medical Center
-
Houston, Texas, United States, 77070
- Methodist Willowbrook Hospital
-
Houston, Texas, United States, 77079
- MD Anderson West Houston
-
League City, Texas, United States, 77573
- MD Anderson League City
-
Sugar Land, Texas, United States, 77478
- MD Anderson in Sugar Land
-
Sugar Land, Texas, United States, 77479
- Houston Methodist Sugar Land Hospital
-
-
Utah
-
American Fork, Utah, United States, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Ogden, Utah, United States, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, United States, 84604
- Utah Valley Regional Medical Center
-
Saint George, Utah, United States, 84770
- Saint George Regional Medical Center
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, United States, 84143
- LDS Hospital
-
-
Vermont
-
Berlin, Vermont, United States, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, United States, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Bristol, Virginia, United States, 24201
- Wellmont Medical Associates-Bristol
-
Charlottesville, Virginia, United States, 22908
- University of Virginia Cancer Center
-
Norton, Virginia, United States, 24273
- Southwest VA Regional Cancer Center
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
Roanoke, Virginia, United States, 24016
- Carilion Clinic Gynecological Oncology
-
-
Washington
-
Aberdeen, Washington, United States, 98520
- Providence Regional Cancer System-Aberdeen
-
Anacortes, Washington, United States, 98221
- Cancer Care Center at Island Hospital
-
Bellevue, Washington, United States, 98005
- Swedish Cancer Institute-Eastside Oncology Hematology
-
Bellingham, Washington, United States, 98225
- PeaceHealth Saint Joseph Medical Center
-
Bellingham, Washington, United States, 98226
- PeaceHealth Medical Group PC
-
Bremerton, Washington, United States, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
-
Bremerton, Washington, United States, 98310
- Harrison Medical Center
-
Burien, Washington, United States, 98166
- Highline Medical Center-Main Campus
-
Centralia, Washington, United States, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, United States, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, United States, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, United States, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, United States, 98003
- Saint Francis Hospital
-
Issaquah, Washington, United States, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, United States, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, United States, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, United States, 98499
- Saint Clare Hospital
-
Longview, Washington, United States, 98632
- PeaceHealth Saint John Medical Center
-
Mount Vernon, Washington, United States, 98274
- Skagit Regional Health Cancer Care Center
-
Poulsbo, Washington, United States, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
Seattle, Washington, United States, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, United States, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, United States, 98109
- FHCC South Lake Union
-
Seattle, Washington, United States, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, United States, 98104
- Minor and James Medical PLLC
-
Seattle, Washington, United States, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, United States, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Seattle, Washington, United States, 98133
- University of Washington Medical Center - Northwest
-
Seattle, Washington, United States, 98133
- Women's Cancer Center of Seattle
-
Sequim, Washington, United States, 98384
- Olympic Medical Cancer Care Center
-
Shelton, Washington, United States, 98584
- Providence Regional Cancer System-Shelton
-
Spokane, Washington, United States, 99218
- Evergreen Hematology and Oncology PS
-
Spokane, Washington, United States, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, United States, 99216
- Cancer Care Northwest-Valley
-
Spokane, Washington, United States, 99218
- Cancer Care Northwest-North Spokane
-
Spokane, Washington, United States, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, United States, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, United States, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, United States, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, United States, 98405
- MultiCare Tacoma General Hospital
-
Tacoma, Washington, United States, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Tacoma, Washington, United States, 98405
- Saint Joseph Medical Center
-
Vancouver, Washington, United States, 98664
- PeaceHealth Southwest Medical Center
-
Vancouver, Washington, United States, 98684
- Compass Oncology Vancouver
-
Walla Walla, Washington, United States, 99362
- Providence Saint Mary Regional Cancer Center
-
Wenatchee, Washington, United States, 98801
- Wenatchee Valley Hospital and Clinics
-
Yakima, Washington, United States, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yakima, Washington, United States, 98902
- Cancer Institutes of Washington PLLC
-
Yelm, Washington, United States, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Fond Du Lac, Wisconsin, United States, 54937
- Aurora Health Center-Fond du Lac
-
Grafton, Wisconsin, United States, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, United States, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, United States, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology Limited at Saint Mary's Hospital
-
Green Bay, Wisconsin, United States, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
-
Marinette, Wisconsin, United States, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marinette, Wisconsin, United States, 54143
- Bay Area Medical Center
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, United States, 53233
- Aurora Sinai Medical Center
-
New Richmond, Wisconsin, United States, 54017
- Cancer Center of Western Wisconsin
-
Oconto Falls, Wisconsin, United States, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, United States, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Sheboygan, Wisconsin, United States, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sturgeon Bay, Wisconsin, United States, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Sturgeon Bay, Wisconsin, United States, 54235
- Green Bay Oncology - Sturgeon Bay
-
Summit, Wisconsin, United States, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, United States, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Wausau, Wisconsin, United States, 54401
- Aspirus Regional Cancer Center
-
West Allis, Wisconsin, United States, 53227
- Aurora West Allis Medical Center
-
-
Wyoming
-
Cheyenne, Wyoming, United States, 82001
- Cheyenne Regional Medical Center-West
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization
- Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
- Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
- Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
- A complete response to front-line chemotherapy must include: negative physical exam, negative pelvic exam and normalization of CA125, if elevated at baseline; although not required, any radiographic assessment of disease status (e.g. CT, magnetic resonance imaging [MRI], positron emission tomography [PET]/CT, etc) obtained following the completion of primary therapy should be considered negative for disease
- All patients must have also had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent (i.e. bevacizumab)
- Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy
- Patients must have clinically evident recurrent disease for the purpose of this study
- Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be more than or equal to 20 mm when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm when measured by spiral CT
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to Common Toxicity Criteria for Adverse Events version (v)4.0 (CTCAE) grade 1
- Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)
- Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
- Total bilirubin =< 1.5 ULN (CTCAE grade 1)
- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal in the absence of liver metastasis; SGOT/AST < 5.0 times ULN in the presence of liver metastasis
- Alkaline phosphatase =< 2.5 times the upper limit of normal in the absence of liver metastasis; alkaline phosphatase < 5.0 times ULN in the presence of liver metastasis
- This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL
- This eligibility criterion does not apply to patients enrolled after August 28, 2011; patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization; patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking
- Patients must have met the pre-entry requirements as specified
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
Exclusion Criteria:
- Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
- Patients receiving concurrent immunotherapy, or radiotherapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded
- Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed above
- Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube, and primary peritoneal) are excluded
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
- Patients with uncontrolled infection
- Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- Patients with >= grade 2 peripheral neuropathy
- Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds; patients with allergic (hypersensitivity) reactions to these chemotherapeutic agents are NOT excluded IF they were successfully retreated following a desensitization program or protocol
- This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are nursing are not eligible for this trial; to date, no fetal studies in animal or humans have been performed; the possibility of harm to a fetus is likely; bevacizumab specifically inhibits VEGF, which is responsible for the formation of new blood vessels during development, and antibodies can cross the placenta; therefore, bevacizumab should not be administered to pregnant women; in addition, there are unknown immediate and long-term consequences of chemotherapy administration to these women; in addition, surgical exploration as mandated by randomization during pregnancy may cause imminent mortal consequences; further, it is not known whether bevacizumab is excreted in human milk; because many drugs are excreted in human milk, bevacizumab should not be administered to nursing women; subjects will be apprised of the large potential risk to a developing fetus
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
- This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
- This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or a history of stroke within 5 years of the first date of treatment on this study
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with clinically significant cardiovascular disease; this includes:
- Patients with significant cardiac conduction abnormalities, i.e. PR interval > 0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block
- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
- Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to registration
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Grade II or greater peripheral vascular disease (exception: episodes of ischemia < 24 hours [hrs] in duration, that are managed non-surgically and without permanent deficit)
- History of cerebrovascular attack (CVA) within six months
- This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
- Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with bevacizumab on cycle #2
- Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of 28 days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of 7 days to begin protocol treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm I (paclitaxel, docetaxel, carboplatin)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1.
Treatment repeats every 21 days.
|
Correlative studies
Given IV
Other Names:
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
|
Experimental: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1.
Treatment repeats every 21 days.
|
Correlative studies
Given IV
Other Names:
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
|
Experimental: Arm III (gemcitabine hydrochloride, carboplatin)
Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
|
Correlative studies
Given IV
Other Names:
Ancillary studies
Other Names:
Given IV
Other Names:
|
Experimental: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.
|
Correlative studies
Given IV
Other Names:
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
Time Frame: The time frame is 82.5 months (median duration of follow-up)
|
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment.
The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months).
The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
|
The time frame is 82.5 months (median duration of follow-up)
|
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
Time Frame: The time frame is 82.5 months (median duration of follow-up).
|
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment.
The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months).
The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
|
The time frame is 82.5 months (median duration of follow-up).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (Chemotherapy Analysis)
Time Frame: Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase
|
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
|
Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase
|
Progression Free Survival (Surgery Analysis)
Time Frame: Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.
|
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
|
Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.
|
Summary of Adverse Events (CTCAE Version 4.0)
Time Frame: During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
|
Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
|
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
|
Patient Reported Quality of Life (Chemotherapy Analysis)
Time Frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
|
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI).
The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients.
It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items).
Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much).
The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
|
1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
|
Patient Reported Physical Function (Chemotherapy Analysis)
Time Frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
|
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36.
The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities.
Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited.
The total PF score is the summation of item scores and then rescaled to 0-100.
A larger score suggests better physical functioning.
|
1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
|
Patient Reported Quality of Life (Surgery Analysis)
Time Frame: 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
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Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI).
The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients.
It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items).
Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much).
The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
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1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
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Patient Reported Physical Functioning (Surgery Analysis)
Time Frame: 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery
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Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36.
The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities.
Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited.
The total PF score is the summation of item scores and then rescaled to 0-100.
A larger score suggests better physical functioning.
This measure was completed by US patients only.
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1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert L Coleman, NRG Oncology
Publications and helpful links
General Publications
- Coleman RL, Spirtos NM, Enserro D, Herzog TJ, Sabbatini P, Armstrong DK, Kim JW, Park SY, Kim BG, Nam JH, Fujiwara K, Walker JL, Casey AC, Alvarez Secord A, Rubin S, Chan JK, DiSilvestro P, Davidson SA, Cohn DE, Tewari KS, Basen-Engquist K, Huang HQ, Brady MF, Mannel RS. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer. N Engl J Med. 2019 Nov 14;381(20):1929-1939. doi: 10.1056/NEJMoa1902626.
- Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Fallopian Tube Diseases
- Neoplasms, Connective Tissue
- Neoplasms, Cystic, Mucinous, and Serous
- Ovarian Neoplasms
- Endometrial Neoplasms
- Neoplasms, Fibrous Tissue
- Neoplasms, Fibroepithelial
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma
- Recurrence
- Adenocarcinoma
- Fallopian Tube Neoplasms
- Cystadenocarcinoma, Serous
- Carcinoma, Endometrioid
- Cystadenocarcinoma
- Adenocarcinoma, Clear Cell
- Carcinoma, Transitional Cell
- Adenocarcinoma, Mucinous
- Brenner Tumor
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Carboplatin
- Paclitaxel
- Antibodies
- Immunoglobulins
- Bevacizumab
- Albumin-Bound Paclitaxel
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Immunoglobulin G
- Endothelial Growth Factors
- Gemcitabine
Other Study ID Numbers
- NCI-2009-00587 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180868 (U.S. NIH Grant/Contract)
- U10CA027469 (U.S. NIH Grant/Contract)
- 09-0205
- GOG-0213 (Other Identifier: CTEP)
- CDR0000546714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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