- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02446600
Testowanie stosowania pojedynczego leku (olaparib) lub połączenia dwóch leków (cediranib i olaparyb) w porównaniu ze zwykłą chemioterapią u kobiet z platynowrażliwym rakiem jajnika, jajowodu lub pierwotnym rakiem otrzewnej
Badanie III fazy porównujące olaparyb w monoterapii lub połączenie cediranibu i olaparybu ze standardową chemioterapią opartą na związkach platyny u kobiet z nawracającym rakiem jajnika, jajowodu lub pierwotnym rakiem otrzewnej wrażliwym na platynę
This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Przegląd badań
Status
Warunki
- Nawracający rak jajowodu
- Nawracający rak jajnika
- Nawracający pierwotny rak otrzewnej
- Rak surowiczo-śluzowy jajnika
- Niezróżnicowany rak jajnika
- Rak jasnokomórkowy jajnika
- Rak przejściowokomórkowy jajowodu
- Rak przejściowokomórkowy jajnika
- Rak jasnokomórkowy jajowodu
- Niezróżnicowany rak jajowodu
- Nawracający gruczolakorak endometrioidalny jajnika
- Guz endometrioidalny jajnika
- Guz surowiczy jajnika
Interwencja / Leczenie
- Lek: Carboplatin
- Lek: Paclitaxel
- Inny: Laboratory Biomarker Analysis
- Inny: Quality-of-Life Assessment
- Procedura: Biospecimen Collection
- Procedura: Computed Tomography
- Procedura: Magnetic Resonance Imaging
- Procedura: Echocardiography Test
- Procedura: Multigated Acquisition Scan
- Inny: Pharmacological Study
- Lek: Gemcitabine Hydrochloride
- Lek: Cediranib Maleate
- Lek: Olaparib
- Lek: Gemcitabine
- Lek: Pegylated Liposomal Doxorubicin Hydrochloride
Szczegółowy opis
PRIMARY OBJECTIVE:
I. Assess the efficacy of either single agent olaparib or the combination of cediranib (cediranib maleate) and olaparib, as measured by progression free survival (PFS), as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
SECONDARY OBJECTIVES:
I. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
II. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, in women with or without deleterious germline breast cancer (BRCA) mutations (gBRCAmt) in the setting of recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.
III. Assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (NFOSI-18), of single agent olaparib or cediranib and olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.
IV. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, in women with or without homologous repair deficiencies as measured by BROCA in the setting of recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.
V. To assess changes in the number of circulating endothelial cells (CECs) following three days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.
VI. To assess whether change in the number of circulating endothelial cells (CECs) following three days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer is prognostic for PFS.
VII. To develop a profile from a panel of angiogenic biomarkers in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer which is associated with PFS, and then validate the predictive value of this biomarker profile.
EXPLORATORY OBJECTIVES:
I. To assess the time from randomization to the first non-study, anti-cancer therapy, surgery or death (TFST) for single-agent olaparib or combination cediranib and olaparib relative to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
II. To assess the time from randomization to the second non-study, anti-cancer therapy, surgery or death (TSST) for single-agent olaparib or combination cediranib and olaparib relative to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
III. Assess the effect on secondary measures of quality of life, as assessed by the treatment side effects (TSE) and function/well-being (F/WB) subscales of the NFOSI-18, sensory neuropathy as measured by the FACT/Gynecologic Oncology Group-Neurotoxicity version 4 (GOG-Ntx-4), and health utility as measured by the Euro Quality of Life-5 Dimension (EQ-5D), of single agent olaparib or cediranib and olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients may be treated with one of the three regimens per investigator discretion.
REGIMEN I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial.
REGIMEN II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
REGIMEN III: Patients receive pegylated liposomal doxorubicin hydrochloride IV and carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 28 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
ARM II: Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
ARM III: Patients receive olaparib PO BID and cediranib maleate PO once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
-
-
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Saitama, Japonia, 350-1298
- Saitama Medical University International Medical Center
-
Tokyo, Japonia, 104 0045
- National Cancer Center Hospital
-
-
Iwate
-
Shiwa-gun, Iwate, Japonia, 028-3695
- Iwate Medical University Hospital
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japonia, 890-8760
- Kagoshima City Hospital
-
-
Tokyo
-
Koto-ku, Tokyo, Japonia, 135-8550
- The Cancer Institute Hospital Of JFCR
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
-
London, Ontario, Kanada, N6A 4L6
- London Regional Cancer Program
-
Ottawa, Ontario, Kanada, K1H 8L6
- Ottawa Hospital and Cancer Center-General Campus
-
Sault Ste. Marie, Ontario, Kanada, P6B 0A8
- Algoma District Cancer Program Sault Area Hospital
-
Toronto, Ontario, Kanada, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
Toronto, Ontario, Kanada, M4N 3M5
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
-
-
Quebec
-
Montreal, Quebec, Kanada, H3T 1E2
- Jewish General Hospital
-
Montreal, Quebec, Kanada, H2X 3E4
- CHUM - Centre Hospitalier de l'Universite de Montreal
-
Montreal, Quebec, Kanada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
-
Québec, Quebec, Kanada, G1R 2J6
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
-
Sherbrooke, Quebec, Kanada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
-
-
-
-
-
Seoul, Korea Południowa, 110-744
- Seoul National University Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, Stany Zjednoczone, 35233
- University of Alabama at Birmingham Cancer Center
-
Mobile, Alabama, Stany Zjednoczone, 36688
- University of South Alabama Mitchell Cancer Institute
-
-
Alaska
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Tucson, Arizona, Stany Zjednoczone, 85704
- Arizona Oncology Associates-West Orange Grove
-
Tucson, Arizona, Stany Zjednoczone, 85710
- Arizona Oncology Associates-Wilmot
-
-
Arkansas
-
Little Rock, Arkansas, Stany Zjednoczone, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
Arroyo Grande, California, Stany Zjednoczone, 93420
- PCR Oncology
-
Carmichael, California, Stany Zjednoczone, 95608
- Mercy San Juan Medical Center
-
Greenbrae, California, Stany Zjednoczone, 94904
- Marin Cancer Care Inc
-
La Jolla, California, Stany Zjednoczone, 92093
- UC San Diego Moores Cancer Center
-
Los Angeles, California, Stany Zjednoczone, 90048
- Cedars-Sinai Medical Center
-
Mountain View, California, Stany Zjednoczone, 94040
- Palo Alto Medical Foundation-Camino Division
-
Mountain View, California, Stany Zjednoczone, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
-
Oakland, California, Stany Zjednoczone, 94611
- Kaiser Permanente-Oakland
-
Palo Alto, California, Stany Zjednoczone, 94301
- Palo Alto Medical Foundation Health Care
-
Roseville, California, Stany Zjednoczone, 95661
- Sutter Roseville Medical Center
-
Sacramento, California, Stany Zjednoczone, 95816
- Sutter Medical Center Sacramento
-
Sacramento, California, Stany Zjednoczone, 95817
- University of California Davis Comprehensive Cancer Center
-
Sacramento, California, Stany Zjednoczone, 95825
- Kaiser Permanente Sacramento Medical Center
-
Sacramento, California, Stany Zjednoczone, 95816
- Mercy Cancer Center - Sacramento
-
San Francisco, California, Stany Zjednoczone, 94115
- Kaiser Permanente-San Francisco
-
San Francisco, California, Stany Zjednoczone, 94158
- UCSF Medical Center-Mission Bay
-
San Francisco, California, Stany Zjednoczone, 94115
- California Pacific Medical Center-Pacific Campus
-
San Luis Obispo, California, Stany Zjednoczone, 93401
- Pacific Central Coast Health Center-San Luis Obispo
-
Santa Clara, California, Stany Zjednoczone, 95051
- Kaiser Permanente Medical Center - Santa Clara
-
Santa Cruz, California, Stany Zjednoczone, 95065
- Palo Alto Medical Foundation-Santa Cruz
-
Santa Rosa, California, Stany Zjednoczone, 95403
- Sutter Pacific Medical Foundation
-
Sunnyvale, California, Stany Zjednoczone, 94086
- Palo Alto Medical Foundation-Sunnyvale
-
Vallejo, California, Stany Zjednoczone, 94589
- Kaiser Permanente-Vallejo
-
Walnut Creek, California, Stany Zjednoczone, 94596
- Kaiser Permanente-Walnut Creek
-
Woodland, California, Stany Zjednoczone, 95695
- Woodland Memorial Hospital
-
-
Colorado
-
Aurora, Colorado, Stany Zjednoczone, 80012
- Rocky Mountain Cancer Centers-Aurora
-
Aurora, Colorado, Stany Zjednoczone, 80045
- UCHealth University of Colorado Hospital
-
Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, Stany Zjednoczone, 80909
- UCHealth Memorial Hospital Central
-
Denver, Colorado, Stany Zjednoczone, 80205
- Kaiser Permanente-Franklin
-
Denver, Colorado, Stany Zjednoczone, 80220
- Rocky Mountain Cancer Centers-Rose
-
Fort Collins, Colorado, Stany Zjednoczone, 80524
- Poudre Valley Hospital
-
Lafayette, Colorado, Stany Zjednoczone, 80026
- Kaiser Permanente-Rock Creek
-
Littleton, Colorado, Stany Zjednoczone, 80120
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree, Colorado, Stany Zjednoczone, 80124
- Kaiser Permanente-Lone Tree
-
Lone Tree, Colorado, Stany Zjednoczone, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Wheat Ridge, Colorado, Stany Zjednoczone, 80401
- Intermountain Health Lutheran Hospital
-
-
Connecticut
-
Fairfield, Connecticut, Stany Zjednoczone, 06824
- Smilow Cancer Hospital Care Center-Fairfield
-
Hartford, Connecticut, Stany Zjednoczone, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, Stany Zjednoczone, 06102
- Hartford Hospital
-
Middletown, Connecticut, Stany Zjednoczone, 06457
- Middlesex Hospital
-
New Britain, Connecticut, Stany Zjednoczone, 06050
- The Hospital of Central Connecticut
-
New Haven, Connecticut, Stany Zjednoczone, 06520
- Yale University
-
Torrington, Connecticut, Stany Zjednoczone, 06790
- Smilow Cancer Hospital-Torrington Care Center
-
Trumbull, Connecticut, Stany Zjednoczone, 06611
- Smilow Cancer Hospital Care Center-Trumbull
-
-
Delaware
-
Newark, Delaware, Stany Zjednoczone, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, Stany Zjednoczone, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Stany Zjednoczone, 19971
- Beebe Health Campus
-
Seaford, Delaware, Stany Zjednoczone, 19973
- TidalHealth Nanticoke / Allen Cancer Center
-
-
District of Columbia
-
Washington D.C., District of Columbia, Stany Zjednoczone, 20016
- Sibley Memorial Hospital
-
-
Florida
-
Gainesville, Florida, Stany Zjednoczone, 32610
- UF Health Cancer Institute - Gainesville
-
-
Georgia
-
Athens, Georgia, Stany Zjednoczone, 30607
- University Cancer and Blood Center LLC
-
Atlanta, Georgia, Stany Zjednoczone, 30309
- Piedmont Hospital
-
Atlanta, Georgia, Stany Zjednoczone, 30342
- Northside Hospital
-
Decatur, Georgia, Stany Zjednoczone, 30033
- Emory Decatur Hospital
-
Macon, Georgia, Stany Zjednoczone, 31201
- Atrium Health Navicent
-
Savannah, Georgia, Stany Zjednoczone, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, Stany Zjednoczone, 31404
- Memorial Health University Medical Center
-
-
Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, Stany Zjednoczone, 96826
- Kapiolani Medical Center for Women and Children
-
-
Idaho
-
Boise, Idaho, Stany Zjednoczone, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Stany Zjednoczone, 83712
- Saint Luke's Cancer Institute - Boise
-
Fruitland, Idaho, Stany Zjednoczone, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, Stany Zjednoczone, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Luke's Cancer Institute - Nampa
-
-
Illinois
-
Aurora, Illinois, Stany Zjednoczone, 60504
- Rush-Copley Medical Center
-
Bloomington, Illinois, Stany Zjednoczone, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare-Canton
-
Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Stany Zjednoczone, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
-
Chicago, Illinois, Stany Zjednoczone, 60612
- John H Stroger Jr Hospital of Cook County
-
Chicago, Illinois, Stany Zjednoczone, 60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
-
Chicago, Illinois, Stany Zjednoczone, 60612
- Rush MD Anderson Cancer Center
-
Decatur, Illinois, Stany Zjednoczone, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Stany Zjednoczone, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Effingham, Illinois, Stany Zjednoczone, 62401
- Crossroads Cancer Center
-
Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare-Eureka
-
Evanston, Illinois, Stany Zjednoczone, 60201
- NorthShore University HealthSystem-Evanston Hospital
-
Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare-Galesburg
-
Geneva, Illinois, Stany Zjednoczone, 60134
- Northwestern Medicine Cancer Center Delnor
-
Glenview, Illinois, Stany Zjednoczone, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
-
Highland Park, Illinois, Stany Zjednoczone, 60035
- NorthShore University HealthSystem-Highland Park Hospital
-
Hinsdale, Illinois, Stany Zjednoczone, 60521
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
-
Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare-Macomb
-
O'Fallon, Illinois, Stany Zjednoczone, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, Stany Zjednoczone, 61350
- Illinois CancerCare-Ottawa Clinic
-
Park Ridge, Illinois, Stany Zjednoczone, 60068
- Advocate Lutheran General Hospital
-
Pekin, Illinois, Stany Zjednoczone, 61554
- Illinois CancerCare-Pekin
-
Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois CancerCare-Peoria
-
Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare-Peru
-
Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, Stany Zjednoczone, 62702
- Springfield Clinic
-
Springfield, Illinois, Stany Zjednoczone, 62781
- Springfield Memorial Hospital
-
Warrenville, Illinois, Stany Zjednoczone, 60555
- Northwestern Medicine Cancer Center Warrenville
-
-
Indiana
-
Indianapolis, Indiana, Stany Zjednoczone, 46260
- Ascension Saint Vincent Indianapolis Hospital
-
-
Iowa
-
Clive, Iowa, Stany Zjednoczone, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Stany Zjednoczone, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Des Moines, Iowa, Stany Zjednoczone, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Stany Zjednoczone, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Stany Zjednoczone, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Iowa City, Iowa, Stany Zjednoczone, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
West Des Moines, Iowa, Stany Zjednoczone, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Kansas City, Kansas, Stany Zjednoczone, 66160
- University of Kansas Cancer Center
-
Pittsburg, Kansas, Stany Zjednoczone, 66762
- Mercy Hospital Pittsburg
-
Topeka, Kansas, Stany Zjednoczone, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
-
Wichita, Kansas, Stany Zjednoczone, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, Stany Zjednoczone, 67208
- Associates In Womens Health
-
-
Kentucky
-
Lexington, Kentucky, Stany Zjednoczone, 40536
- University of Kentucky/Markey Cancer Center
-
Louisville, Kentucky, Stany Zjednoczone, 40202
- Norton Hospital Pavilion and Medical Campus
-
Louisville, Kentucky, Stany Zjednoczone, 40241
- Norton Brownsboro Hospital and Medical Campus
-
Louisville, Kentucky, Stany Zjednoczone, 40207
- Norton Suburban Hospital and Medical Campus
-
-
Louisiana
-
Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Mary Bird Perkins Cancer Center
-
Baton Rouge, Louisiana, Stany Zjednoczone, 70817
- Woman's Hospital
-
Covington, Louisiana, Stany Zjednoczone, 70433
- Women's Cancer Care-Covington
-
New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner Medical Center Jefferson
-
-
Maine
-
Bangor, Maine, Stany Zjednoczone, 04401
- Eastern Maine Medical Center
-
Brewer, Maine, Stany Zjednoczone, 04412
- Lafayette Family Cancer Center-EMMC
-
Scarborough, Maine, Stany Zjednoczone, 04074
- MaineHealth Maine Medical Center- Scarborough
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
-
Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Stany Zjednoczone, 21204
- Greater Baltimore Medical Center
-
Easton, Maryland, Stany Zjednoczone, 21601
- University of Maryland Shore Medical Center at Easton
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Stany Zjednoczone, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, Stany Zjednoczone, 02111
- Tufts Medical Center
-
Burlington, Massachusetts, Stany Zjednoczone, 01805
- Lahey Clinic
-
-
Michigan
-
Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan Rogel Cancer Center
-
Ann Arbor, Michigan, Stany Zjednoczone, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Brownstown, Michigan, Stany Zjednoczone, 48183
- Henry Ford Cancer Institute-Downriver
-
Clinton Township, Michigan, Stany Zjednoczone, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Stany Zjednoczone, 48201
- Wayne State University/Karmanos Cancer Institute
-
Escanaba, Michigan, Stany Zjednoczone, 49829
- OSF Saint Francis Hospital and Medical Group
-
Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Weisberg Cancer Treatment Center
-
Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
-
Flint, Michigan, Stany Zjednoczone, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo, Michigan, Stany Zjednoczone, 49007
- West Michigan Cancer Center
-
Lansing, Michigan, Stany Zjednoczone, 48912
- University of Michigan Health - Sparrow Lansing
-
Manistique, Michigan, Stany Zjednoczone, 49854
- Schoolcraft Memorial Hospital
-
Pontiac, Michigan, Stany Zjednoczone, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Southfield, Michigan, Stany Zjednoczone, 48075
- Henry Ford Health Providence Southfield Hospital
-
Traverse City, Michigan, Stany Zjednoczone, 49684
- Munson Medical Center
-
West Bloomfield, Michigan, Stany Zjednoczone, 48322
- Henry Ford West Bloomfield Hospital
-
-
Minnesota
-
Bemidji, Minnesota, Stany Zjednoczone, 56601
- Sanford Joe Lueken Cancer Center
-
Burnsville, Minnesota, Stany Zjednoczone, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy Hospital
-
Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
-
Mankato, Minnesota, Stany Zjednoczone, 56001
- Mayo Clinic Health Systems-Mankato
-
Maple Grove, Minnesota, Stany Zjednoczone, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Stany Zjednoczone, 55109
- Saint John's Hospital - Healtheast
-
Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota/Masonic Cancer Center
-
Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Stany Zjednoczone, 55102
- United Hospital
-
Shakopee, Minnesota, Stany Zjednoczone, 55379
- Saint Francis Regional Medical Center
-
Woodbury, Minnesota, Stany Zjednoczone, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Mississippi
-
Jackson, Mississippi, Stany Zjednoczone, 39216
- University of Mississippi Medical Center
-
Jackson, Mississippi, Stany Zjednoczone, 39216
- Saint Dominic-Jackson Memorial Hospital
-
-
Missouri
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Saint Francis Medical Center
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Mercy Hospital Joplin
-
Springfield, Missouri, Stany Zjednoczone, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Stany Zjednoczone, 63110
- Barnes-Jewish Hospital
-
St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
-
-
Montana
-
Billings, Montana, Stany Zjednoczone, 59101
- Billings Clinic Cancer Center
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, Stany Zjednoczone, 59901
- Logan Health Medical Center
-
Missoula, Montana, Stany Zjednoczone, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Stany Zjednoczone, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Stany Zjednoczone, 68847
- CHI Health Good Samaritan
-
Omaha, Nebraska, Stany Zjednoczone, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Stany Zjednoczone, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68130
- Alegent Health Lakeside Hospital
-
-
Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Women's Cancer Center of Nevada
-
-
New Hampshire
-
Dover, New Hampshire, Stany Zjednoczone, 03820
- Wentworth-Douglass Hospital
-
Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Nashua, New Hampshire, Stany Zjednoczone, 03063
- Dartmouth Cancer Center - Nashua
-
-
New Jersey
-
Basking Ridge, New Jersey, Stany Zjednoczone, 07920
- Memorial Sloan Kettering Basking Ridge
-
Camden, New Jersey, Stany Zjednoczone, 08103
- Cooper Hospital University Medical Center
-
Englewood, New Jersey, Stany Zjednoczone, 07631
- Englewood Hospital and Medical Center
-
Voorhees Township, New Jersey, Stany Zjednoczone, 08043
- MD Anderson Cancer Center at Cooper-Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Stany Zjednoczone, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Albuquerque, New Mexico, Stany Zjednoczone, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Stany Zjednoczone, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Brooklyn, New York, Stany Zjednoczone, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, Stany Zjednoczone, 14263
- Roswell Park Cancer Institute
-
Commack, New York, Stany Zjednoczone, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, Stany Zjednoczone, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, Stany Zjednoczone, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Stany Zjednoczone, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Stany Zjednoczone, 14642
- University of Rochester
-
The Bronx, New York, Stany Zjednoczone, 10461
- Montefiore Medical Center-Einstein Campus
-
Uniondale, New York, Stany Zjednoczone, 11553
- Memorial Sloan Kettering Nassau
-
White Plains, New York, Stany Zjednoczone, 10601
- Dickstein Cancer Treatment Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Durham, North Carolina, Stany Zjednoczone, 27710
- Duke University Medical Center
-
Goldsboro, North Carolina, Stany Zjednoczone, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Jacksonville, North Carolina, Stany Zjednoczone, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Pinehurst, North Carolina, Stany Zjednoczone, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh, North Carolina, Stany Zjednoczone, 27609
- Duke Cancer Center Raleigh
-
Wilmington, North Carolina, Stany Zjednoczone, 28401
- Novant Health New Hanover Regional Medical Center
-
Winston-Salem, North Carolina, Stany Zjednoczone, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Bismarck, North Dakota, Stany Zjednoczone, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Stany Zjednoczone, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Stany Zjednoczone, 58122
- Sanford Broadway Medical Center
-
Minot, North Dakota, Stany Zjednoczone, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, Stany Zjednoczone, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, Stany Zjednoczone, 44304
- Summa Health System - Akron Campus
-
Beachwood, Ohio, Stany Zjednoczone, 44122
- UHHS-Chagrin Highlands Medical Center
-
Cincinnati, Ohio, Stany Zjednoczone, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Stany Zjednoczone, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Stany Zjednoczone, 45247
- TriHealth Cancer Institute-Westside
-
Cleveland, Ohio, Stany Zjednoczone, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Stany Zjednoczone, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Stany Zjednoczone, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Stany Zjednoczone, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Stany Zjednoczone, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Stany Zjednoczone, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Stany Zjednoczone, 43214
- Columbus Oncology and Hematology Associates Inc
-
Dayton, Ohio, Stany Zjednoczone, 45405
- Grandview Hospital
-
Findlay, Ohio, Stany Zjednoczone, 45840
- Orion Cancer Care
-
Mayfield Heights, Ohio, Stany Zjednoczone, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, Stany Zjednoczone, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Sylvania, Ohio, Stany Zjednoczone, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Wadsworth, Ohio, Stany Zjednoczone, 44281
- University Hospitals Sharon Health Center
-
Westlake, Ohio, Stany Zjednoczone, 44145
- UHHS-Westlake Medical Center
-
Wright-Patterson Air Force Base, Ohio, Stany Zjednoczone, 45433
- Wright-Patterson Medical Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Stany Zjednoczone, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Bend, Oregon, Stany Zjednoczone, 97701
- Saint Charles Health System
-
Eugene, Oregon, Stany Zjednoczone, 97401
- Willamette Valley Cancer Center
-
Gresham, Oregon, Stany Zjednoczone, 97030
- Legacy Mount Hood Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97227
- Kaiser Permanente Northwest
-
Tualatin, Oregon, Stany Zjednoczone, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Abington, Pennsylvania, Stany Zjednoczone, 19001
- Jefferson Abington Hospital
-
Bethlehem, Pennsylvania, Stany Zjednoczone, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Danville, Pennsylvania, Stany Zjednoczone, 17822
- Geisinger Medical Center
-
Ephrata, Pennsylvania, Stany Zjednoczone, 17522
- Ephrata Cancer Center
-
Gettysburg, Pennsylvania, Stany Zjednoczone, 17325
- Adams Cancer Center
-
Lancaster, Pennsylvania, Stany Zjednoczone, 17602
- Lancaster General Hospital
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
- UPMC Hillman Cancer Center
-
Sayre, Pennsylvania, Stany Zjednoczone, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
Selinsgrove, Pennsylvania, Stany Zjednoczone, 17870
- Geisinger Medical Oncology-Selinsgrove
-
West Reading, Pennsylvania, Stany Zjednoczone, 19611
- Reading Hospital
-
Williamsport, Pennsylvania, Stany Zjednoczone, 17701
- UPMC Susquehanna
-
York, Pennsylvania, Stany Zjednoczone, 17403
- WellSpan Health-York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, Stany Zjednoczone, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Anderson, South Carolina, Stany Zjednoczone, 29621
- AnMed Health Cancer Center
-
Charleston, South Carolina, Stany Zjednoczone, 29425
- Medical University of South Carolina
-
Gaffney, South Carolina, Stany Zjednoczone, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Stany Zjednoczone, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Stany Zjednoczone, 29601
- Saint Francis Hospital
-
Greer, South Carolina, Stany Zjednoczone, 29651
- Gibbs Cancer Center-Pelham
-
Hilton Head Island, South Carolina, Stany Zjednoczone, 29926-3827
- South Carolina Cancer Specialists PC
-
Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Spartanburg Medical Center
-
Union, South Carolina, Stany Zjednoczone, 29379
- SMC Center for Hematology Oncology Union
-
-
South Dakota
-
Rapid City, South Dakota, Stany Zjednoczone, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Johnson City, Tennessee, Stany Zjednoczone, 37604
- Wellmont Medical Associates Oncology and Hematology-Johnson City
-
Kingsport, Tennessee, Stany Zjednoczone, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Stany Zjednoczone, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Knoxville, Tennessee, Stany Zjednoczone, 37916
- Covenant Health Cancer Centers
-
Knoxville, Tennessee, Stany Zjednoczone, 37932
- Covenant Health Cancer Centers - West
-
Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Austin, Texas, Stany Zjednoczone, 78731
- Texas Oncology - Central Austin Cancer Center
-
Austin, Texas, Stany Zjednoczone, 78745
- Texas Oncology - South Austin Cancer Center
-
Bedford, Texas, Stany Zjednoczone, 76022
- Texas Oncology Bedford
-
Dallas, Texas, Stany Zjednoczone, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Fort Worth, Texas, Stany Zjednoczone, 76104
- Texas Oncology - Fort Worth Cancer Center
-
Houston, Texas, Stany Zjednoczone, 77030
- Houston Methodist Hospital
-
Houston, Texas, Stany Zjednoczone, 77070
- Methodist Willowbrook Hospital
-
Sugar Land, Texas, Stany Zjednoczone, 77479
- Houston Methodist Sugar Land Hospital
-
The Woodlands, Texas, Stany Zjednoczone, 77380
- Texas Oncology-The Woodlands
-
-
Utah
-
Murray, Utah, Stany Zjednoczone, 84107
- Intermountain Medical Center
-
Salt Lake City, Utah, Stany Zjednoczone, 84106
- Utah Cancer Specialists-Salt Lake City
-
St. George, Utah, Stany Zjednoczone, 84770
- Saint George Regional Medical Center
-
-
Virginia
-
Charlottesville, Virginia, Stany Zjednoczone, 22908
- University of Virginia Cancer Center
-
Richmond, Virginia, Stany Zjednoczone, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Kennewick, Washington, Stany Zjednoczone, 99336
- Kadlec Clinic Hematology and Oncology
-
Mount Vernon, Washington, Stany Zjednoczone, 98274
- Skagit Valley Hospital
-
Mount Vernon, Washington, Stany Zjednoczone, 98274
- Skagit Regional Health Cancer Care Center
-
Seattle, Washington, Stany Zjednoczone, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Stany Zjednoczone, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, Stany Zjednoczone, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Stany Zjednoczone, 98109
- Fred Hutchinson Cancer Center
-
Seattle, Washington, Stany Zjednoczone, 98133
- University of Washington Medical Center - Northwest
-
Seattle, Washington, Stany Zjednoczone, 98133
- Women's Cancer Center of Seattle
-
Vancouver, Washington, Stany Zjednoczone, 98686
- Legacy Salmon Creek Hospital
-
Wenatchee, Washington, Stany Zjednoczone, 98801
- Wenatchee Valley Hospital and Clinics
-
-
West Virginia
-
Charleston, West Virginia, Stany Zjednoczone, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huntington, West Virginia, Stany Zjednoczone, 25701
- Edwards Comprehensive Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Stany Zjednoczone, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Stany Zjednoczone, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Stany Zjednoczone, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Lutheran Medical Center
-
Ladysmith, Wisconsin, Stany Zjednoczone, 54848
- Marshfield Medical Center - Ladysmith
-
Madison, Wisconsin, Stany Zjednoczone, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marinette, Wisconsin, Stany Zjednoczone, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Stany Zjednoczone, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, Stany Zjednoczone, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, Stany Zjednoczone, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Stany Zjednoczone, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rice Lake, Wisconsin, Stany Zjednoczone, 54868
- Marshfield Medical Center-Rice Lake
-
Stevens Point, Wisconsin, Stany Zjednoczone, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Stevens Point, Wisconsin, Stany Zjednoczone, 54481
- Aspirus Cancer Care - Stevens Point
-
Sturgeon Bay, Wisconsin, Stany Zjednoczone, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Waukesha, Wisconsin, Stany Zjednoczone, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Stany Zjednoczone, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, Stany Zjednoczone, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Stany Zjednoczone, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Stany Zjednoczone, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
-
Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory; Note: Due to the long acceptance of germline BRCA testing through Myriad, Myriad testing will be accepted; if testing for germline BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement is required; please collect a copy of Myriad or other BRCA mutational analysis (positive or VUS or negative) reports
- Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for > 6 months (or 182 days) after last receipt of platinum-based therapy
- Patients must have had a complete clinical response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy
-
Patients must have signed an approved informed consent and authorization permitting release of personal health information
-
Patients must have evaluable disease - defined as one of the following:
- Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease OR
- Evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related) AND a cancer antigen 125 (CA125) that has doubled from the post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)
-
Prior therapy:
- Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy
- Patients may have received an unlimited number of platinum-based therapies in the recurrent setting
- Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line
- Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
- Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor
- Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable
-
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Karnofsky >= 60%)
-
Absolute neutrophil count >= 1,500/mcL
-
Platelets >= 100,000/mcL
-
Hemoglobin >= 10 g/dL
-
Creatinine =< the institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
-
Urine protein: creatinine ratio (UPC) of =< 1 or less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with >= 2+ proteinuria on dipstick must also have a 24 hour urine collection demonstrating =< 500 mg over 24 hours
-
Total bilirubin =< 1.5 x the institutional ULN
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional ULN
-
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm
-
Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
-
Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol
-
Patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to Arm III
-
Cediranib has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
-
Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits
-
Age >= 18
Exclusion Criteria:
-
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions
-
Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks
-
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
-
Patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib, pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
-
Patients may not have previously received a PARP inhibitor
-
CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease
-
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib
-
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution
-
History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
-
History of intra-abdominal abscess within the past 3 months
-
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
-
Dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)
-
Any concomitant or prior invasive malignancies with the following curatively treated exceptions:
- Treated limited stage basal cell or squamous cell carcinoma of the skin
- Carcinoma in situ of the breast or cervix
- Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
- Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence
-
Patients with any of the following:
- History of myocardial infarction within six months
- Unstable angina
- Resting electrocardiogram (ECG) with clinically significant abnormal findings
- New York Heart Association (NYHA) classification of III or IV
-
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines
-
Patients with the following risk factors should have a baseline cardiac function assessment:
- Prior treatment with anthracyclines
- Prior treatment with trastuzumab
- Prior central thoracic radiation therapy (RT), including RT to the heart
- History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
- Prior history of impaired cardiac function
-
-
History of stroke or transient ischemic attack within six months
-
Any prior history of hypertensive crisis or hypertensive encephalopathy
-
Clinically significant peripheral vascular disease or vascular disease (including aortic aneurysm or aortic dissection)
-
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
-
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements
-
Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study
-
Known HIV-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy
-
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments
-
No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
-
No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Arm I (platinum-based chemotherapy)
See detailed description. |
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Correlative studies Ancillary studies
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo MRI
Inne nazwy:
Undergo ECHO
Inne nazwy:
Undergo MUGA
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
|
|
Eksperymentalny: Arm II (olaparib)
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial. |
Correlative studies Ancillary studies
Inne nazwy:
Undergo blood sample collection
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo MRI
Inne nazwy:
Undergo ECHO
Inne nazwy:
Undergo MUGA
Inne nazwy:
Correlative studies Given PO
Inne nazwy:
|
|
Eksperymentalny: Arm III (olaparib, cediranib maleate)
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial. |
Correlative studies Ancillary studies
Inne nazwy:
Undergo blood sample collection
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo MRI
Inne nazwy:
Undergo ECHO
Inne nazwy:
Undergo MUGA
Inne nazwy:
Correlative studies Given PO
Inne nazwy:
Given PO
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Ramy czasowe: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.
|
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments. |
The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Survival
Ramy czasowe: Approximately 30 months
|
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments. |
Approximately 30 months
|
|
Frequency and Severity of Adverse Effects
Ramy czasowe: During treatment period and up to 100 days after stopping the study treatment, up to 39 months.
|
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%. |
During treatment period and up to 100 days after stopping the study treatment, up to 39 months.
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
Ramy czasowe: Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment
|
Disease-related physical symptoms were measured by the Disease-Related Symptom-Physical (DRS-P) subscale of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NCCN/FOSI-18). The DRS-P subscale is composed of 9 items. For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The DRS-P score ranges 0-36 with a larger score suggesting better QOL (Quality of Life) or less symptoms. This analysis did not include the Japanese cohort. |
Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment
|
Inne miary wyników
Miara wyniku |
Ramy czasowe |
|---|---|
|
Czas od randomizacji do pierwszego braku badania, leczenia przeciwnowotworowego lub śmierci
Ramy czasowe: Do 5 lat
|
Do 5 lat
|
|
Czas od randomizacji do drugiego braku badania, leczenia przeciwnowotworowego lub śmierci
Ramy czasowe: Do 5 lat
|
Do 5 lat
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Joyce F Liu, NRG Oncology
Publikacje i pomocne linki
Publikacje ogólne
- Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
- Liu JF, Brady MF, Matulonis UA, Miller A, Kohn EC, Swisher EM, Cella D, Tew WP, Cloven NG, Muller CY, Bender DP, Moore RG, Michelin DP, Waggoner SE, Geller MA, Fujiwara K, D'Andre SD, Carney M, Alvarez Secord A, Moxley KM, Bookman MA. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Jul 1;40(19):2138-2147. doi: 10.1200/JCO.21.02011. Epub 2022 Mar 15.
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Szacowany)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Choroby układu hormonalnego
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Nowotwory
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Choroby narządów płciowych, kobiety
- Nowotwory gruczołów dokrewnych
- Choroby jajników
- Choroby przydatków
- Nowotwory narządów płciowych, kobiety
- Zaburzenia gonad
- Choroby jajowodów
- Nowotwory jajnika
- Nowotwory jajowodu
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Techniki śledcze
- Techniki laboratoryjne kliniczne
- Techniki i procedury diagnostyczne
- Diagnoza
- Węglowodory
- Cykloparafiny
- Węglowodory, Alicyklic
- Węglowodory, cykliczne
- Terpeny
- Węglowodany
- Policykliczne aromatyczne węglowodory
- Węglowodory, aromatyczne
- Związki policykliczne
- Glikozydy
- Kompleksy koordynacyjne
- Taksoidy
- Cyklodekan
- Diterpenes
- Deoksycytydyna
- Cytydyna
- Nukleozydy pirymidynowe
- Pirymidyn
- Ekonomia i organizacje opieki zdrowotnej
- Techniki chemii, analityczne
- Analiza widma
- Antracykliny
- Naftaceny
- Aminoglikozydy
- Daunorubicyna
- Ekonomika
- Gemcytabina
- Karboplatyna
- Doksorubicyna
- Paklitaksel
- Prowadzenie okazów
- Spektroskopia rezonansu magnetycznego
- liposomalna doksorubicyna
- Olaparib
- Cediranib
- Podatki
Inne numery identyfikacyjne badania
- NCI-2015-00606
- U10CA180868 (Grant/umowa NIH USA)
- NCI-2015-00606 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- s16-01480
- NRG-GY004 (Inny identyfikator: CTEP)
- NRG-GY004
- NRG-GY004 (Inny identyfikator: NRG Oncology)
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