Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

March 8, 2019 updated by: Gynecologic Oncology Group

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 pelvic radiation therapy alone is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy.

SECONDARY OBJECTIVES:

I. To compare survival between the two treatment groups. II. To compare patterns of failure between the two treatment groups. III. To compare physical functioning, fatigue and neurotoxicity between the two treatment groups.

IV. To examine associations between primary comorbid illnesses and obesity on survival, fatigue and physical functioning.

V. To evaluate the psychometric properties (such as construct validity, reliability, sensitivity to treatment and responsiveness over time) of the Patient-Reported-Outcomes Measurement Information System (PROMIS) Fatigue Short form 1, and to evaluate fatigue measurement equivalence between women with endometrial cancer and age-matched women from the general United States (US) population.

TERTIARY OBJECTIVES:

I. To evaluate the ability of gene expression signatures in early stage endometrial cancer to predict recurrence and to explore the association between gene expression signatures in early stage endometrial cancer and clinical characteristics and outcome.

II. To bank whole blood specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

ARM II: Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses 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 annually thereafter for up to 5 years.

Study Type

Interventional

Enrollment (Actual)

601

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 135-720
    - Gangnam Severance Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 139-706
    - Korea Cancer Center Hospital
  - Seoul, Korea, Republic of, 135-720
    - Yongdong Severence Hospital
  - Suwon, Korea, Republic of, 443-721
    - Ajou University Hospital
- Incheon
  - Jung-gu, Incheon, Korea, Republic of, 400-711
    - Inha University
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham Cancer Center
  - Mobile, Alabama, United States, 36688
    - University of South Alabama Mitchell Cancer Institute
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- Arizona
  - Phoenix, Arizona, United States, 85013
    - Saint Joseph's Hospital and Medical Center
  - Tucson, Arizona, United States, 85719
    - University of Arizona Cancer Center-North Campus
  - Tucson, Arizona, United States, 85704
    - Arizona Oncology Associates-West Orange Grove
- California
  - Auburn, California, United States, 95603
    - Sutter Cancer Centers Radiation Oncology Services-Auburn
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Cameron Park, California, United States, 95682
    - Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  - Carmichael, California, United States, 95608
    - Mercy San Juan Medical Center
  - Concord, California, United States, 94520
    - John Muir Medical Center-Concord Campus
  - 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
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oakland-Broadway
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Orange, California, United States, 92868
    - Saint Joseph Hospital - Orange
  - Palo Alto, California, United States, 94304
    - Stanford Cancer Institute Palo Alto
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Rohnert Park, California, United States, 94928
    - Rohnert Park Cancer Center
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, United States, 95661
    - Sutter Cancer Centers Radiation Oncology Services-Roseville
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - Sacramento, California, United States, 95819
    - Mercy General Hospital Radiation Oncology Center
  - San Diego, California, United States, 92103
    - University of California San Diego
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94115
    - UCSF Medical Center-Mount Zion
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Sylmar, California, United States, 91342
    - Olive View-University of California Los Angeles Medical Center
  - Vacaville, California, United States, 95687
    - Sutter Cancer Centers Radiation Oncology Services-Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Walnut Creek, California, United States, 94598
    - John Muir Medical Center-Walnut Creek
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Aurora, Colorado, United States, 80010
    - Colorado Gynecologic Oncology Group
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - 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
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80222
    - Colorado Cancer Research Program NCORP
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Grand Junction, Colorado, United States, 81501
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - Saint Vincent's Medical Center
  - Danbury, Connecticut, United States, 06810
    - Danbury Hospital
  - Farmington, Connecticut, United States, 06030
    - University of Connecticut
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale University
  - Norwich, Connecticut, United States, 06360
    - Eastern Connecticut Hematology and Oncology Associates
  - Norwich, Connecticut, United States, 06360
    - William Backus Hospital
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - MedStar Washington Hospital Center
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Clearwater, Florida, United States, 33756
    - Morton Plant Hospital
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Fort Myers, Florida, United States, 33905
    - Florida Gynecologic Oncology
  - Jacksonville, Florida, United States, 32204
    - Southeast Gynecologic Oncology Associates
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Orlando, Florida, United States, 32803
    - Florida Hospital Orlando
  - Orlando, Florida, United States, 32806
    - UF Cancer Center at Orlando Health
  - Orlando, Florida, United States, 32806
    - Florida Institute of Research Medicine and Surgery-Cancer Center
  - Saint Petersburg, Florida, United States, 33701
    - Women's Cancer Associates
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, United States, 30303
    - Grady Health System
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital
  - Augusta, Georgia, United States, 30912
    - Augusta University Medical Center
  - Columbus, Georgia, United States, 31904
    - John B Amos Cancer Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center-Gainesville
  - Macon, Georgia, United States, 31201
    - Central Georgia Gynecologic Oncology
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - The Cancer Center of Hawaii-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc-POB II
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Oncology Inc-Kuakini
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
- Idaho
  - Boise, Idaho, United States, 83712
    - Saint Luke's Mountain States Tumor Institute
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Mountain States Tumor Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Mountain States Tumor Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Mountain States Tumor Institute - Nampa
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Mountain States Tumor Institute-Twin Falls
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Health
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - 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
  - Chicago, Illinois, United States, 60612
    - John H Stroger Jr Hospital of Cook County
  - Decatur, Illinois, United States, 62526
    - Heartland Cancer Research NCORP
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates Incorporated
  - Hinsdale, Illinois, United States, 60521
    - Sudarshan K Sharma MD Limited-Gynecologic Oncology
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Oak Lawn, Illinois, United States, 60453-2699
    - Advocate Christ Medical Center
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - 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
    - Valley Radiation Oncology
  - Rockford, Illinois, United States, 61104
    - Swedish American Hospital
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Winfield, Illinois, United States, 60190
    - Northwestern Medicine Central DuPage Hospital
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - Franciscan Saint Francis Health-Beech Grove
  - Dyer, Indiana, United States, 46311
    - Franciscan Saint Margaret Health-Dyer Campus
  - 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
  - Fort Wayne, Indiana, United States, 46805
    - Parkview Hospital Randallia
  - Fort Wayne, Indiana, United States, 46804
    - Radiation Oncology Associates PC
  - Hammond, Indiana, United States, 46320
    - Franciscan Saint Margaret Health-Hammond Campus
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, United States, 46260
    - Saint Vincent Hospital and Health Care Center
  - Indianapolis, Indiana, United States, 46219
    - IU Health Central Indiana Cancer Centers-East
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - 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
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - 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, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Mason City, Iowa, United States, 50401
    - Mercy Medical Center - North Iowa
- Kansas
  - Anthony, Kansas, United States, 67003
    - Hospital District Sixth of Harper County
  - 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
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - Liberal, Kansas, United States, 67901
    - Southwest Medical Center
  - 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, 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
    - Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Wesley Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Edgewood, Kentucky, United States, 41017
    - Saint Elizabeth Medical Center South
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
  - Louisville, Kentucky, United States, 40202
    - The James Graham Brown Cancer Center at University of Louisville
  - Pikeville, Kentucky, United States, 41501
    - Pikeville Medical Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70817
    - Woman's Hospital
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70112
    - University Medical Center New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Louisiana State University Health Science Center
  - Shreveport, Louisiana, United States, 71103
    - Louisiana State University Health Sciences Center Shreveport
- Maine
  - Portland, Maine, United States, 04102
    - Maine Medical Center-Bramhall Campus
- 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
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Baltimore, Maryland, United States, 21229
    - Saint Agnes Hospital
  - Bethesda, Maryland, United States, 20889-5600
    - Walter Reed National Military Medical Center
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Medical School
  - Worcester, Massachusetts, United States, 01605
    - University of Massachusetts Memorial Health Care
- Michigan
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Cancer Research Consortium of West Michigan NCORP
  - 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
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
- 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
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - 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, 55455
    - University of Minnesota/Masonic Cancer Center
  - 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, 55426
    - Park Nicollet Frauenshuh Cancer Center
  - 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
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - 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, 64108
    - Truman Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Kansas City, Missouri, United States, 64154
    - The University of Kansas Cancer Center-North
  - Kansas City, Missouri, United States, 64114
    - Saint Joseph Health Center
  - 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
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology Inc
  - Saint Joseph, Missouri, United States, 64507
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63141
    - Saint Louis-Cape Girardeau CCOP
  - 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
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59102
    - Montana Cancer Consortium NCORP
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Great Falls, Montana, United States, 59405
    - Berdeaux, Donald MD (UIA Investigator)
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68198
    - University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
  - Las Vegas, Nevada, United States, 89169
    - 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 Hampshire
  - Manchester, New Hampshire, United States, 03103
    - Elliot Hospital
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - Livingston, New Jersey, United States, 07039
    - Saint Barnabas Medical Center
  - Long Branch, New Jersey, United States, 07740
    - Monmouth Medical Center
  - 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
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
  - Newark, New Jersey, United States, 07101
    - Rutgers New Jersey Medical School
  - Phillipsburg, New Jersey, United States, 08865
    - Saint Luke's Hospital-Warren Campus
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Vineland, New Jersey, United States, 08360
    - Inspira Medical Center Vineland
  - Voorhees, New Jersey, United States, 08043
    - Virtua 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, 11203
    - State University of New York Downstate Medical Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Canandaigua, New York, United States, 14424
    - Sands Cancer Center
  - Fresh Meadows, New York, United States, 11365
    - New York Hospital Medical Center of Queens
  - Lake Success, New York, United States, 11042
    - Northwell Health NCORP
  - Lake Success, New York, United States, 11042
    - Northwell Health/Center for Advanced Medicine
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - Mineola, New York, United States, 11501
    - NYU Winthrop 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, 10019
    - Mount Sinai West
  - 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
  - New York, New York, United States, 10003
    - Mount Sinai Union Square
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Highland Hospital
  - Rochester, New York, United States, 14626
    - University Radiation Oncology
  - 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, 28816
    - Hope Women's Cancer Centers-Asheville
  - 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
  - Concord, North Carolina, United States, 28025
    - Atrium Health Cabarrus/LCI-Concord
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Raleigh, North Carolina, United States, 27609
    - Duke Raleigh Hospital
  - Raleigh, North Carolina, United States, 27607
    - Duke Women's Cancer Care Raleigh
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Wilmington, North Carolina, United States, 28401
    - New Hanover Regional Medical Center/Zimmer Cancer Center
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Barberton, Ohio, United States, 44203
    - Summa Barberton Hospital
  - Canton, Ohio, United States, 44710
    - Aultman Health Foundation
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional 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, 45219
    - University of Cincinnati/Barrett Cancer Center
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - 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, 43228
    - Doctors 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
    - Miami Valley Hospital North
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial 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
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Salem, Ohio, United States, 44460
    - UH Seidman Cancer Center at Salem Regional Medical Center
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Wooster, Ohio, United States, 44691
    - Cancer Treatment Center
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - 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
- Oregon
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer 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, 97227
    - Compass Oncology Rose Quarter
  - Salem, Oregon, United States, 97301
    - Salem Hospital
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Memorial Hospital
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18015
    - Saint Luke's University Hospital-Bethlehem Campus
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Hanover, Pennsylvania, United States, 17331
    - Cherry Tree Cancer 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
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - 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, 15213
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - 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
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Main Line Health NCORP
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Hospital
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women and Infants Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Hospital
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29601
    - Greenville Health System Cancer Institute-Andrews
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Faris
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute-Eastside
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System Cancer Institute-Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System Cancer Institute-Spartanburg
- South Dakota
  - 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
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga's Program in Women's Oncology
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga Gynecological Oncology
  - Knoxville, Tennessee, United States, 37920
    - University of Tennessee - Knoxville
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, United States, 37208
    - Meharry Medical College
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology PLLC- Centennial Medical Center
- Texas
  - Arlington, Texas, United States, 76014
    - Texas Oncology-Arlington South
  - Austin, Texas, United States, 78705
    - Texas Oncology-Austin Midtown
  - Austin, Texas, United States, 78731
    - Texas Oncology - Central Austin Cancer Center
  - Austin, Texas, United States, 78745
    - Texas Oncology - South Austin Cancer Center
  - Bedford, Texas, United States, 76022
    - Texas Oncology Bedford
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Dallas, Texas, United States, 75246
    - Baylor University Medical Center
  - Dallas, Texas, United States, 75390
    - Clements University Hospital
  - Denton, Texas, United States, 76210
    - Texas Oncology-Denton South
  - Fort Sam Houston, Texas, United States, 78234
    - Brooke Army Medical Center
  - Fort Worth, Texas, United States, 76104
    - Baylor All Saints Medical Center at Fort Worth
  - Fort Worth, Texas, United States, 76104
    - The Klabzuba Cancer 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, 77030
    - The Methodist Hospital System
  - Houston, Texas, United States, 77024
    - Memorial Hermann Memorial City Medical Center
  - Lackland Air Force Base, Texas, United States, 78236
    - Wilford Hall Medical Center
  - Longview, Texas, United States, 75601
    - Texas Oncology-Longview Cancer Center
  - Odessa, Texas, United States, 79761
    - West Texas Cancer Center
  - Round Rock, Texas, United States, 78681
    - Texas Oncology - Round Rock Cancer Center
  - Sherman, Texas, United States, 75090
    - Texas Cancer Center-Sherman
  - Sugar Land, Texas, United States, 77479
    - Texas Oncology Cancer Center Sugar Land
  - Tyler, Texas, United States, 75702
    - Tyler Cancer Center
  - Wichita Falls, Texas, United States, 76310
    - Texas Oncology-Wichita Falls Texoma Cancer Center
- Utah
  - Cedar City, Utah, United States, 84720
    - Sandra L Maxwell Cancer Center
  - Murray, Utah, United States, 84107
    - Intermountain Medical 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
    - Dixie Medical Center Regional Cancer Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists-Salt Lake City
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84103
    - Intermountain Health Care
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
- Virginia
  - Annandale, Virginia, United States, 22003
    - Northern Virginia Pelvic Surgery Associates
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
  - Roanoke, Virginia, United States, 24016
    - Carilion Clinic Gynecological Oncology
- Washington
  - 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
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital Regional 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, 98109
    - Seattle Cancer Care Alliance
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, United States, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98133
    - Northwest Hospital
  - Sequim, Washington, United States, 98384
    - Olympic Medical Cancer Care Center
  - Spokane, Washington, United States, 99204
    - Rockwood Cancer Treatment Center-DHEC-Downtown
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, United States, 98405
    - Saint Joseph Medical Center
  - 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
- West Virginia
  - Wheeling, West Virginia, United States, 26003
    - Wheeling Hospital/Schiffler Cancer Center
- Wisconsin
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Mequon, Wisconsin, United States, 53097
    - Columbia Saint Mary's Hospital - Ozaukee
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert and The Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, United States, 53211
    - Columbia Saint Mary's Water Tower Medical Commons
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53405
    - Wheaton Franciscan Cancer Care - All Saints
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

To be considered eligible to participate in this trial, all patients must have undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic approach) is strongly encouraged
Peritoneal cytology should be obtained on entering the peritoneal cavity, as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual (https://gogmember.gog.org/manuals/pdf/surgman.pdf); pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged (as staged patients enrolled on GOG-0210-molecular markers in endometrial carcinoma are eligible for this study)
- The procedures may be performed via laparotomy or laparoscopy (including robot-assisted) as per the surgeon?s preference; the surgeon must record in the operative report whether a lymphadenectomy was performed (see link above to Surgical Procedures Manual) or not; a specific number of lymph nodes removed will not be utilized for eligibility, but the operative report should reflect that the procedure performed was consistent with the procedures described in the GOG Surgical Manual
If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment computed tomography (CT)/magnetic resonance imaging (MRI) is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease); post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed
For the purposes of description, patients will be staged according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 staging system; eligibility is defined based on clinical-pathologic features; patients with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
- Age >= 70 years with one risk factor
- Age >= 50 with 2 risk factors
- Age >= 18 years with 3 risk factors
- Risk factors: grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ? myometrial invasion; patients with these risk criteria may be enrolled with either positive or negative cytology
Patients with stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors
Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement), and with peritoneal cytology negative for malignancy
Patients must have GOG performance status 0, 1, or 2
Absolute neutrophil count (ANC) >= 1,500/mcl (equivalent to Common Toxicity Criteria [CTCAE version [v] 3.0] grade 1)
Platelets >= 100,000/mcl (CTCAE v3.0 grade 0-1)
Serum creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0
- Note: If serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min
Bilirubin =< 1.5 x ULN (CTCAE v3.0 grade 1)
Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE grade 0-1)
Alkaline phosphatase =< 2.5 x ULN (CTCAE grade 0-1)
Neuropathy (sensory and motor) =< CTCAE v3.0 grade 1
Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

Patients who have already received non-surgical therapy for endometrial cancer including chemotherapy, radiation (example, pre-operative or post-operative brachytherapy), hormonal or biologic therapy
Patients identified with pathologically confirmed spread of cancer beyond the uterus and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other anatomic sites, or patients with serous or clear cell histology and with positive cytologic washings
Patients with nodal (for patients who did not have nodal dissection performed) or distant disease determined based on imaging studies; patients with suspicious nodes that have been biopsied (re-staging operation, fine needle aspiration [FNA]) and are pathologically negative will be eligible
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are excluded if their previous cancer treatment contraindicates this protocol therapy; specifically, patients who have received prior radiotherapy directed to treat disease within the abdominal cavity or pelvis are excluded
Prior radiation of localized cancer of the breast, head and neck, thyroid, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease
Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease
Patients who have contraindications to pelvic radiation therapy (RT) (e.g. pelvic kidney, connective tissue disease, inflammatory bowel disease, etc.) should be screened in advance and not be considered eligible for the trial
Patients with recurrent endometrial cancer
Patients with surgical or clinical, FIGO 2009 stage III or IV endometrial carcinoma
Patients with non-epithelial uterine malignancies such as uterine carcinosarcoma or leiomyosarcoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm I (pelvic radiation therapy) Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.	Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: 3-Dimensional Conformal Radiation Therapy Undergo pelvic radiation therapy Other Names: 3-dimensional radiation therapy 3D CONFORMAL RADIATION THERAPY 3D CRT 3D-CRT Conformal Therapy Radiation Conformal Therapy Radiation: Intensity-Modulated Radiation Therapy Undergo pelvic radiation therapy Other Names: IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation: Internal Radiation Therapy Undergo vaginal cuff brachytherapy Other Names: Internal Radiation Brachytherapy Radiation Brachytherapy BRACHYTHERAPY internal radiation
EXPERIMENTAL: Arm II (brachytherapy, paclitaxel, carboplatin) Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Radiation: Internal Radiation Therapy Undergo vaginal cuff brachytherapy Other Names: Internal Radiation Brachytherapy Radiation Brachytherapy BRACHYTHERAPY internal radiation

Participant Group / Arm

Intervention / Treatment

ACTIVE_COMPARATOR: Arm I (pelvic radiation therapy)

Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

Other: Laboratory Biomarker Analysis

Correlative studies

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Radiation: 3-Dimensional Conformal Radiation Therapy

Undergo pelvic radiation therapy

Other Names:

3-dimensional radiation therapy
3D CONFORMAL RADIATION THERAPY
3D CRT
3D-CRT
Conformal Therapy
Radiation Conformal Therapy

Radiation: Intensity-Modulated Radiation Therapy

Undergo pelvic radiation therapy

Other Names:

IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy

Radiation: Internal Radiation Therapy

Undergo vaginal cuff brachytherapy

Other Names:

Internal Radiation Brachytherapy
Radiation Brachytherapy
BRACHYTHERAPY
internal radiation

EXPERIMENTAL: Arm II (brachytherapy, paclitaxel, carboplatin)

Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis

Correlative studies

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Drug: Paclitaxel

Given IV

Other Names:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Radiation: Internal Radiation Therapy

Undergo vaginal cuff brachytherapy

Other Names:

Internal Radiation Brachytherapy
Radiation Brachytherapy
BRACHYTHERAPY
internal radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrence or Death Events at Primary Analysis Time Frame: Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years	Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact	Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Death Events Time Frame: Overall survival is measured from study enrollment for up to 10 years.	The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.	Overall survival is measured from study enrollment for up to 10 years.
Number of Participants With Sites of Recurrence Time Frame: Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years	Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event.	Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years
Patient Reported Fatigue Time Frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment	Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue 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 scale. The FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue.	Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment
Patient-reported Neurotoxicity Time Frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.	Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx 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 scale. The Ntx score ranges 0-16 with a large score suggesting less neurotoxicity.	Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.
Patient-reported Quality of Life Time Frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment	Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En 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-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL	Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment

Other Outcome Measures

Outcome Measure	Time Frame
Gene Expression Based Risk Score Time Frame: Baseline	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Marcus E Randall, NRG Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Randall ME, Filiaci V, McMeekin DS, von Gruenigen V, Huang H, Yashar CM, Mannel RS, Kim JW, Salani R, DiSilvestro PA, Burke JJ, Rutherford T, Spirtos NM, Terada K, Anderson PR, Brewster WR, Small W, Aghajanian CA, Miller DS. Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer. J Clin Oncol. 2019 Jul 20;37(21):1810-1818. doi: 10.1200/JCO.18.01575. Epub 2019 Apr 17.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2009

Primary Completion (ACTUAL)

December 29, 2014

Study Registration Dates

First Submitted

December 11, 2008

First Submitted That Met QC Criteria

December 11, 2008

First Posted (ESTIMATE)

December 12, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

GOG-0249 (OTHER: CTEP)
U10CA180868 (U.S. NIH Grant/Contract)
U10CA027469 (U.S. NIH Grant/Contract)
NCI-2009-00610 (REGISTRY: CTRP (Clinical Trial Reporting Program))
CDR0000629591

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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Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

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

Other Study ID Numbers

Clinical Trials on Obesity

Clinical Trials on Laboratory Biomarker Analysis

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