Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

September 28, 2021 updated by: Gynecologic Oncology Group

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I or II serous (uterine papillary serous carcinoma [UPSC]) or clear cell endometrial carcinoma and positive cytology.

SECONDARY OBJECTIVES:

I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (i.e., increases survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with FIGO 2009 stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.

II. To compare the regimens with respect to acute and late adverse effects of therapy.

III. To determine the impact of patient-reported quality of life during and following treatment for up to 1 year with the two treatment regimens.

TERTIARY OBJECTIVES:

I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and whole blood specimens for future research.

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

ARM I: Patients receive cisplatin intravenously (IV) on days 1 and 29. Patients also undergo radiation therapy once daily (QD), 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

813

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

Canada
- Quebec
  - Montreal, Quebec, Canada, H3H 2R9
    - The Research Institute of the McGill University Health Centre (MUHC)
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University Department of Oncology
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H3T 1M5
    - Saint Mary's Hospital
  - Montreal, Quebec, Canada, H3A 1A1
    - McGill University Health Centre at Royal Victoria Hospital
Korea, Republic of
- - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06273
    - Gangnam Severance Hospital
  - Seoul, Korea, Republic of, 139-706
    - Korea Cancer Center Hospital
  - Suwon, Korea, Republic of, 443-721
    - Ajou University Hospital
- Daegu
  - Dalseo-gu, Daegu, Korea, Republic of, 42601
    - Keimyung University-Dongsan Medical Center
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
    - National Cancer Center-Korea
- Korea
  - Seoul, Korea, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Korea, Republic of, 137-040
    - Catholic University of Korea-Seoul Saint Mary's Hospital
- Kyeonggi-do
  - Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham Cancer Center
  - Huntsville, Alabama, United States, 35805
    - Tennessee Valley Gynecologic Oncology
  - Mobile, Alabama, United States, 36688
    - University of South Alabama Mitchell Cancer Institute
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- Arizona
  - Phoenix, Arizona, United States, 85013
    - Saint Joseph's Hospital and Medical Center
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - 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
  - Fremont, California, United States, 94538
    - Kaiser Permanente-Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente-Fresno
  - La Jolla, California, United States, 92093
    - UC San Diego Moores Cancer Center
  - Long Beach, California, United States, 90806
    - Long Beach Memorial Medical Center-Todd Cancer Institute
  - Los Angeles, California, United States, 90095
    - UCLA / Jonsson Comprehensive Cancer Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Newport Beach, California, United States, 92663
    - Gynecologic Oncology Associates-Newport Beach
  - 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 Barbara, California, United States, 93105
    - Cancer Center of Santa Barbara
  - 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, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - 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
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
- Connecticut
  - Bridgeport, Connecticut, United States, 06610
    - Bridgeport Hospital
  - Bridgeport, Connecticut, United States, 06606
    - Hartford HealthCare - Saint Vincent's Medical Center
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - 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, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - TidalHealth Nanticoke / Allen Cancer Center
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - AdventHealth Altamonte
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Jacksonville, Florida, United States, 32204
    - Saint Vincent's Medical Center
  - Jacksonville, Florida, United States, 32204
    - Southeast Gynecologic Oncology Associates
  - Kissimmee, Florida, United States, 34744
    - AdventHealth Kissimmee
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Health Hollis Cancer Center
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, United States, 33133
    - Mercy Hospital
  - Miami, Florida, United States, 33136
    - Jackson Memorial Hospital-Holtz Children's Hospital
  - Orlando, Florida, United States, 32806
    - Orlando Health Cancer Institute
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
  - Orlando, Florida, United States, 32822
    - AdventHealth East Orlando
  - Panama City, Florida, United States, 32401
    - Bay Medical Center
  - Sarasota, Florida, United States, 34239
    - Sarasota Memorial Hospital
  - Winter Park, Florida, United States, 32792
    - AdventHealth Winter Park
- 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, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital
  - Columbus, Georgia, United States, 31904
    - John B Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Dekalb Medical Center
  - Fayetteville, Georgia, United States, 30214
    - Piedmont Fayette Hospital
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center-Gainesville
  - Macon, Georgia, United States, 31201
    - Central Georgia Gynecologic Oncology
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 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
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Moanalua Medical Center
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - 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, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Lewiston, Idaho, United States, 83501
    - Saint Joseph Regional Medical Center
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - 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
    - John H Stroger Jr Hospital of Cook County
  - Chicago, Illinois, United States, 60608
    - Mount Sinai Hospital Medical Center
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Heartland Cancer Research NCORP
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Hinsdale, Illinois, United States, 60521
    - Sudarshan K Sharma MD Limited-Gynecologic Oncology
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Carle Cancer Institute Normal
  - 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
    - Radiation Oncology of Northern Illinois
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61615
    - OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Rockford, Illinois, United States, 61114
    - SwedishAmerican Regional Cancer Center/ACT
  - Rockford, Illinois, United States, 61104
    - Swedish American Hospital
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- 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
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Munster, Indiana, United States, 46321
    - The Community Hospital
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - 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
  - Des Moines, Iowa, United States, 50307
    - Mercy Capitol
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center-Sioux City
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Spencer, Iowa, United States, 51301
    - Abben Cancer Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Prairie Village, Kansas, United States, 66208
    - Kansas City NCI Community Oncology Research Program
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Wichita NCI Community Oncology Research Program
  - Wichita, Kansas, United States, 67214
    - Wesley Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
  - Edgewood, Kentucky, United States, 41017
    - Saint Elizabeth Medical Center South
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Louisville, Kentucky, United States, 40202
    - Norton Hospital Pavilion and Medical Campus
  - Louisville, Kentucky, United States, 40202
    - The James Graham Brown Cancer Center at University of Louisville
  - Louisville, Kentucky, United States, 40207
    - Norton Suburban Hospital and Medical Campus
  - Pikeville, Kentucky, United States, 41501
    - Pikeville Medical Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, United States, 70809
    - Hematology/Oncology Clinic PLLC
  - 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
    - Tulane University Health Sciences Center
  - New Orleans, Louisiana, United States, 70112
    - University Medical Center New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Louisiana State University Health Science Center
  - New Orleans, Louisiana, United States, 70115
    - Touro Infirmary
  - Shreveport, Louisiana, United States, 71103
    - LSU Health Sciences Center at Shreveport
  - Shreveport, Louisiana, United States, 71103
    - Willis-Knighton Medical and Cancer Center
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Portland, Maine, United States, 04102
    - Maine Medical Center-Bramhall Campus
  - Scarborough, Maine, United States, 04074
    - Maine Medical Center- Scarborough Campus
- Maryland
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, United States, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical 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
    - Christiana Care - Union Hospital
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Massachusetts
  - Attleboro, Massachusetts, United States, 02703
    - Sturdy Memorial Hospital
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Springfield, Massachusetts, United States, 01199
    - Baystate Medical Center
  - Worcester, Massachusetts, United States, 01655
    - UMass Memorial Medical Center - University Campus
  - Worcester, Massachusetts, United States, 01605
    - UMass Memorial Medical Center - Memorial Division
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital - Dearborn
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - Escanaba, Michigan, United States, 49829
    - Green Bay Oncology - Escanaba
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley 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
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center-Columbus
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - 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
  - Troy, Michigan, United States, 48085
    - William Beaumont Hospital - Troy
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- 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
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology Inc
  - 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, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - 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, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Montana Cancer Consortium NCORP
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment 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)
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - 21st Century Oncology-Henderson
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89169
    - Nevada Cancer Research Foundation NCORP
  - Las Vegas, Nevada, United States, 89109
    - 21st Century Oncology
  - Las Vegas, Nevada, United States, 89128
    - 21st Century Oncology-Vegas Tenaya
  - Las Vegas, Nevada, United States, 89148
    - 21st Century Oncology-Fort Apache
  - 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
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
  - Manchester, New Hampshire, United States, 03102
    - Norris Cotton Cancer Center-Manchester
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University 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
  - Newark, New Jersey, United States, 07101
    - Rutgers New Jersey Medical School
  - Paramus, New Jersey, United States, 07652
    - The Valley Hospital-Luckow Pavilion
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital
  - Sparta, New Jersey, United States, 07871
    - Sparta Cancer Treatment Center
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Voorhees, New Jersey, United States, 08043
    - Virtua Voorhees
  - Voorhees, New Jersey, United States, 08043
    - MD Anderson Cancer Center at Cooper-Voorhees
  - Westwood, New Jersey, United States, 07675
    - Valley Health System-Hematology/Oncology
- 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
  - 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
  - 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, 10065
    - NYP/Weill Cornell Medical 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, 14606
    - Wilmot Cancer Institute Radiation Oncology at Greece
  - 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
  - Valhalla, New York, United States, 10595
    - New York Medical College
  - Valhalla, New York, United States, 10595
    - Westchester Medical Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28816
    - Hope Women's Cancer Centers-Asheville
  - Burlington, North Carolina, United States, 27215
    - Cone Health Cancer Center at Alamance Regional
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Presbyterian Medical Center
  - Concord, North Carolina, United States, 28025
    - Atrium Health Cabarrus/LCI-Concord
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
  - Raleigh, North Carolina, United States, 27609
    - Duke Raleigh Hospital
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Health System - Akron Campus
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Canton, Ohio, United States, 44710
    - Aultman Health Foundation
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45202
    - Oncology Hematology Care Inc-Eden Park
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc-Anderson
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 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
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45459
    - Dayton NCI Community Oncology Research Program
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - 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
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - 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
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at Saint Francis
  - Tulsa, Oklahoma, United States, 74146
    - Warren Clinic Oncology-Tulsa
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Jefferson Abington Hospital
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Bethlehem, Pennsylvania, United States, 18015
    - Saint Luke's University Hospital-Bethlehem Campus
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - 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
  - Pittsburgh, Pennsylvania, United States, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Scranton, Pennsylvania, United States, 18508
    - Hematology and Oncology Associates of North East Pennsylvania
  - Upland, Pennsylvania, United States, 19013
    - Crozer-Chester Medical Center
  - West Chester, Pennsylvania, United States, 19380
    - Chester County Hospital
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women and Infants Hospital
- South Carolina
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29601
    - Greenville Health System Cancer Institute-Andrews
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Rapid City, South Dakota, United States, 57701
    - Black Hills Obstetrics and Gynecology
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga's Program In Women's Oncology
  - Knoxville, Tennessee, United States, 37920
    - University of Tennessee - Knoxville
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology PLLC- Centennial Medical Center
- Texas
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Galveston, Texas, United States, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77030
    - Memorial Hermann Texas Medical Center
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital / Huntsman Intermountain Cancer Center
  - Cedar City, Utah, United States, 84720
    - Sandra L Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - 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
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Roanoke, Virginia, United States, 24016
    - Carilion Clinic Gynecological Oncology
- Washington
  - Auburn, Washington, United States, 98001
    - MultiCare Auburn Medical Center
  - Bellevue, Washington, United States, 98004
    - Overlake Medical Center
  - Bellingham, Washington, United States, 98226
    - PeaceHealth Medical Group PC
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Bremerton, Washington, United States, 98310
    - Harrison Medical Center
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital Regional Cancer Care Center
  - Olympia, Washington, United States, 98506-5166
    - Providence - Saint Peter Hospital
  - Olympia, Washington, United States, 98507
    - Capital Medical Center
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Puyallup, Washington, United States, 98372
    - MultiCare Good Samaritan Hospital
  - 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 - Montlake
  - 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
    - University of Washington Medical Center - Northwest
  - Sequim, Washington, United States, 98384
    - Olympic Medical Cancer Care Center
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99204
    - MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, United States, 98405
    - MultiCare Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - Northwest NCI Community Oncology Research Program
  - Tacoma, Washington, United States, 98405
    - Saint Joseph Medical Center
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital and Clinics
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center
  - Wheeling, West Virginia, United States, 26003
    - Wheeling Hospital/Schiffler Cancer Center
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54701
    - HSHS Sacred Heart Hospital
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54301
    - Bellin Memorial Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53405
    - Ascension All Saints Hospital
  - Rhinelander, Wisconsin, United States, 54501
    - Ascension Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Stevens Point, Wisconsin, United States, 54481
    - Ascension Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Weston, Wisconsin, United States, 54476
    - Diagnostic and Treatment Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer 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:

All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma
- Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
- Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional
Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
White blood cell (WBC) >= 3,000/mcl
Absolute neutrophil count (ANC) >= 1,500/mcl
Platelet count >= 100,000/mcl
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN)
Alkaline phosphatase =< 2.5 times ULN
Bilirubin =< 1.5 times ULN
Creatinine =< institutional ULN
Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
Patients who have signed an approved informed consent and authorization permitting release of personal health information
Entry into the study is limited to no more than 8 weeks from the date of surgery

Exclusion Criteria:

Patients with carcinosarcoma
Patients with recurrent endometrial cancer
Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension
Patients who have had pelvic or abdominal radiation therapy
Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
Patients with an estimated survival of less than three months
Patients with FIGO 2009 stage IVB endometrial cancer
Patients with parenchymal liver metastases
Patients who have received prior chemotherapy for endometrial cancer
Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment

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
EXPERIMENTAL: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin) Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.	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 Drug: Cisplatin Given IV Other Names: CDDP Cis-diamminedichloridoplatinum Cismaplat Cisplatinum Neoplatin Platinol Abiplatin Blastolem Briplatin Cis-diammine-dichloroplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cisplatina Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy Irradiate Irradiated Radiation Radiotherapeutics RT Therapy, Radiation irradiation RADIOTHERAPY Radiation: Internal Radiation Therapy Undergo brachytherapy Other Names: Internal Radiation Brachytherapy Radiation Brachytherapy BRACHYTHERAPY internal radiation
ACTIVE_COMPARATOR: Arm II (paclitaxel and carboplatin) Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.	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 Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)

Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

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

Drug: Cisplatin

Given IV

Other Names:

CDDP
Cis-diamminedichloridoplatinum
Cismaplat
Cisplatinum
Neoplatin
Platinol
Abiplatin
Blastolem
Briplatin
Cis-diammine-dichloroplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cisplatina
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Peyrone's Chloride
Peyrone's Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin

Drug: Paclitaxel

Given IV

Other Names:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Radiation: Radiation Therapy

Undergo radiation therapy

Other Names:

Cancer Radiotherapy
Irradiate
Irradiated
Radiation
Radiotherapeutics
RT
Therapy, Radiation
irradiation
RADIOTHERAPY

Radiation: Internal Radiation Therapy

Undergo brachytherapy

Other Names:

Internal Radiation Brachytherapy
Radiation Brachytherapy
BRACHYTHERAPY
internal radiation

ACTIVE_COMPARATOR: Arm II (paclitaxel and carboplatin)

Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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

Drug: Paclitaxel

Given IV

Other Names:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrence, Progression or Death Time Frame: Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.	Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.	Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 Time Frame: Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment	The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.	Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0 Time Frame: Assessed every 6 months for 3 years	The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.	Assessed every 6 months for 3 years
Overall Survival Time Frame: From entry into the study to death or the date of last contact, assessed up to 8 years	Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.	From entry into the study to death or the date of last contact, assessed up to 8 years
Patient-reported Peripheral Neuropathy Symptoms Time Frame: Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment	Patient reported peripheral neuropathy symptoms was 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 suggests less peripheral neuropathy symptoms.	Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment
Patient-reported Quality of Life (QOL) Time Frame: Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment	Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It 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 was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). 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 FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.	Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment

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: Daniela E Matei, 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

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)

June 29, 2009

Primary Completion (ACTUAL)

February 15, 2016

Study Completion (ANTICIPATED)

July 28, 2024

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (ESTIMATE)

July 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

GOG-0258 (OTHER: CTEP)
U10CA180868 (U.S. NIH Grant/Contract)
U10CA027469 (U.S. NIH Grant/Contract)
NCI-2011-01951 (REGISTRY: CTRP (Clinical Trial Reporting Program))
10-00685
CDR0000649079

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.

Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced 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

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 Completion (ANTICIPATED)

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