Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

October 27, 2022 updated by: GOG Foundation

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival rates. II. To determine acute and long-term toxicities. III. To determine patterns of disease recurrence. IV. To determine the association between radiation protocol compliance and outcomes.

V. To determine patient quality of life, including psycho-sexual health.

TERTIARY OBJECTIVES:

I. To determine the association between the results of a follow-up positron emission tomography (PET) scan performed 4-6 months post completion of chemoradiation and outcomes for all patients in the trial.

II. To determine the biological predictors of patients' outcomes based on translational laboratory studies of blood and tissue specimens.

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

ARM I: Patients receive cisplatin intravenously (IV) over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.

ARM II: Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo baseline tumor biopsy and blood collection for future correlative studies.

Patients complete the European Organization for Research and Treatment of Cancer (EORTC) Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at baseline, during, and after completion of study treatment.

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

Study Type

Interventional

Enrollment (Actual)

926

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
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Hopital Notre-Dame
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University Department of Oncology
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Universite de Montreal
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • China
    • Shanghai
      • Guangdong Province, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital and Research Centre
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital Singapore
  • 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
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at Saint Joseph's
      • Phoenix, Arizona, United States, 85012
        • Gynecologic Oncology Group of Arizona
      • Phoenix, Arizona, United States, 85013
        • Saint Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates-Biltmore Cancer Center
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates-West Orange Grove
      • Tucson, Arizona, United States, 85710
        • Arizona Oncology Associates-Wilmot
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Auburn, California, United States, 95602
        • Sutter Auburn Faith Hospital
      • Auburn, California, United States, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burlingame, California, United States, 94010
        • Mills-Peninsula Medical Center
      • Cameron Park, California, United States, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Concord, California, United States, 94520
        • John Muir Medical Center-Concord Campus
      • Davis, California, United States, 95616
        • Sutter Davis Hospital
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • 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, 94301
        • Palo Alto Medical Foundation Health Care
      • 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, 95816
        • Mercy Cancer Center - Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Rafael, California, United States, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Cruz, California, United States, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Rosa, California, United States, 95403
        • Sutter Pacific Medical Foundation
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • 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
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
      • 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
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • 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, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80222
        • Western States Cancer Research NCORP
      • Durango, Colorado, United States, 81301
        • Southwest Oncology PC
      • Englewood, Colorado, United States, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Greenwood Village, Colorado, United States, 80111
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • 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
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Parker, Colorado, United States, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, United States, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers-Thornton
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • 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
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Gainesville, Florida, United States, 32610
        • University of Florida Health Science Center - Gainesville
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital-Holtz Children's Hospital
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • 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
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center-Gainesville
      • Macon, Georgia, United States, 31201
        • Central Georgia Gynecologic Oncology
    • Hawaii
      • '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
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Cancer Clinic
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • 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
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • 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
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • 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
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • 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
      • 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
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital Pavilion and Medical Campus
      • Louisville, Kentucky, United States, 40241
        • Norton Brownsboro Hospital and Medical Campus
    • 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
        • 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
    • Maine
      • 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, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center - Memorial Division
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • 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
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota/Masonic Cancer Center
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • 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
      • 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
        • Benefis Healthcare- Sletten Cancer Institute
      • 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
    • 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, 89169
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Wentworth-Douglass Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • 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
      • Voorhees, New Jersey, United States, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87109
        • Lovelace Radiation Oncology
      • 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
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • Brooklyn, New York, United States, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Fresh Meadows, New York, United States, 11365
        • New York Hospital Medical Center of Queens
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • 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, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Sleepy Hollow, New York, United States, 10591
        • Memorial Sloan Kettering Sleepy Hollow
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • 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
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • 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 Consortium NCORP
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati/Barrett Cancer Center
      • 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
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Wright-Patterson Air Force Base, Ohio, United States, 45433
        • Wright-Patterson Medical 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
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University School of Medicine
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC-Shadyside Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading 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
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, United States, 29379
        • MGC Hematology Oncology-Union
    • 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
    • Texas
      • 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
        • Texas Oncology at Baylor Charles A Sammons Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - Fort Worth 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, 77026-1967
        • Lyndon Baines Johnson General Hospital
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Memorial Hermann Texas Medical Center
      • Odessa, Texas, United States, 79761
        • West Texas Cancer Center
      • Sugar Land, Texas, United States, 77479
        • Houston Methodist Sugar Land Hospital
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain 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
    • Virginia
      • 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
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Gig Harbor, Washington, United States, 98335
        • MultiCare Gig Harbor Medical Park
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, United States, 82414
        • Billings Clinic-Cody
      • 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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:

    • Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
  • White blood cells (WBC) >= 3.0 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelet count >= 100 x 10^9/L
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN (if both tests are done, both results need to be =< 2.5 x ULN)
  • Creatinine =< ULN (Common Toxicity Criteria [CTC] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
  • Written informed consent

Exclusion Criteria:

  • Any previous pelvic radiotherapy
  • Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT])
  • FIGO 2008 stage IIIA disease
  • Patients assessed at presentation as requiring interstitial brachytherapy treatment
  • Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
  • Previous chemotherapy for this tumor
  • Evidence of distant metastases
  • Prior diagnosis of Crohn's disease or ulcerative colitis
  • Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4)
  • Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
  • Patients who are pregnant or lactating
  • Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
  • Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who are known to be human immunodeficiency virus (HIV) positive

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (cisplatin, radiation therapy, brachytherapy)
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.
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
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
  • Peyrone''s Chloride
  • Peyrone''s Salt
Radiation: Brachytherapy
Undergo brachytherapy
Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
Experimental: Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour 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
  • Carboplatinum
  • 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
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
  • Peyrone''s Chloride
  • Peyrone''s Salt
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Radiation: Brachytherapy
Undergo brachytherapy
Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate at 5 Years
Time Frame: 5 years from study randomization
Estimate for probability of overall survival at 5 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
5 years from study randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival Rate at 5 Years
Time Frame: 5 years from study randomization
Estimate for probability of progression free at 5 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the time of disease progression, death from any cause or date of last contact, whichever occurs first. Disease progression is defined by increasing clinical, radiological or pathological evidence of disease from participant entry to when investigator deems a progression. RECIST V1.0 was not used to determine response on this study.
5 years from study randomization
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year
Time Frame: 1 year after randomization
Number of participants with a maximum grade of 3 or higher for pre-specified adverse events that occurred during the first year after randomization. Adverse events are graded and categorized using CTCAE v4.0.
1 year after randomization
Patterns of Disease Recurrence
Time Frame: through study completion an average of 60 months
Number of patients for the site of disease recurrence. Disease was considered as persistent if participant had evidence of disease at study entry and disease did not progress during study. Disease status was considered locoregional alone if a participant had disease progression in the pelvis region including vagina after study entry. Disease status was considered distant if a participant had disease progression outside the pelvis (for example the abdomen and lung) after study entry. Criteria used to determine the no progression group includes participants that expired without documentation of progression.
through study completion an average of 60 months
Radiation Protocol Compliance
Time Frame: Average duration of 7 weeks
Radiation protocol compliance measured by external beam dose delivered
Average duration of 7 weeks
Quality of Life for Global Health Status
Time Frame: Baseline and 12 months
Quality of Life measured by change of global health status score from baseline to 12 months follow-up. A cancer-specific questionnaire with 30 items which summarize as five functioning scales, a global health status/quality of life scale, three symptom scales and six single items assessing additional symptoms and perceived financial impact. The minimum global health status score was 0 and the maximum global health status score was 100. A higher global health status score means better outcome.
Baseline and 12 months

Collaborators and Investigators

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

Sponsor

GOG Foundation

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathleen N Moore, 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)

January 9, 2012

Primary Completion (Actual)

July 9, 2021

Study Completion (Actual)

July 9, 2021

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZGOG-0902-GOG-0274 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2011-02978 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • ANZGOG-0902/GOG-0274/RTOG-1174
  • CDR0000706698
  • GOG-0274
  • RTOG-1174
  • ANZGOG-0902
  • S12-01864

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.

Clinical Trials on Cervical Adenocarcinoma

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe