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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414608
First Posted: August 11, 2011
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  Purpose
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.

Condition Intervention Phase
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Chemotherapeutic Agent Toxicity Cognitive Side Effects of Cancer Therapy Psychological Impact of Cancer Radiation Toxicity Sexual Dysfunction and Infertility Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer Drug: Carboplatin Drug: Cisplatin Radiation: External Beam Radiation Therapy Radiation: Internal Radiation Therapy Drug: Paclitaxel Other: Quality-of-Life Assessment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: From randomization to death from any cause, assessed at 5 years ]
    Described with Kaplan-Meier curves and unadjusted logrank tests.


Secondary Outcome Measures:
  • Patterns of disease recurrence [ Time Frame: Up to 5 years ]
  • Progression-free survival rate [ Time Frame: From randomization to the time of disease progression as determined by the investigator or death from any cause, assessed at 3 years ]
  • Progression-free survival rate [ Time Frame: From randomization to the time of disease progression as determined by the investigator or death from any cause, assessed at 5 years ]
  • Quality of life including psychosexual health [ Time Frame: Up to 36 months ]
  • Radiation protocol compliance [ Time Frame: Up to 5 years ]
  • Rate of acute and long-term toxicities [ Time Frame: Up to 5 years ]

Estimated Enrollment: 900
Actual Study Start Date: January 9, 2012
Estimated Primary Completion Date: July 9, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Cisplatin
Given IV
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
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
Drug: Cisplatin
Given IV
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Drug: Paclitaxel
Given IV
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414608


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
United States, Alaska
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Arizona Oncology Associates-Biltmore Cancer Center
Phoenix, Arizona, United States, 85016
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States, 85704
Arizona Oncology Associates-Wilmot
Tucson, Arizona, United States, 85710
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills-Peninsula Medical Center
Burlingame, California, United States, 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
Sutter Davis Hospital
Davis, California, United States, 95616
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Memorial Medical Center
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Mercy Medical Group
Sacramento, California, United States, 95816
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94086
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States, 94589
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
United States, Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States, 80220
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Southwest Oncology PC
Durango, Colorado, United States, 81301
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States, 80111
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States, 80228
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States, 80260
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
University of Florida
Gainesville, Florida, United States, 32610
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Northside Hospital
Atlanta, Georgia, United States, 30342
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States, 30501
United States, Hawaii
The Cancer Center of Hawaii-Leeward
'Ewa Beach, Hawaii, United States, 96706
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Northwestern University
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Cancer Care Center of Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
The Community Hospital
Munster, Indiana, United States, 46321
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States, 40202
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
Louisiana State University Health Science Center
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
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United Hospital
Saint Paul, Minnesota, United States, 55102
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Wentworth-Douglass Hospital
Dover, New Hampshire, United States, 03820
United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Jersey Shore Medical Center
Neptune City, New Jersey, United States, 07753
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
Lovelace Radiation Oncology
Albuquerque, New Mexico, United States, 87109
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States, 88011
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
New York Hospital Medical Center of Queens
Fresh Meadows, New York, United States, 11365
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Queens Hospital Center
Jamaica, New York, United States, 11432
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU Winthrop Hospital
Mineola, New York, United States, 11501
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Lenox Hill Hospital
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Highland Hospital
Rochester, New York, United States, 14620
University of Rochester
Rochester, New York, United States, 14642
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, United States, 10591
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
United States, North Carolina
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States, 27215
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States, 28025
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States, 27104
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Kettering Medical Center
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Drexel University School of Medicine
Philadelphia, Pennsylvania, United States, 19102
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Reading Hospital
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States, 29341
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
MGC Hematology Oncology-Union
Union, South Carolina, United States, 29379
United States, South Dakota
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, United States, 57701
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology - Central Austin Cancer Center
Austin, Texas, United States, 78731
Texas Oncology - South Austin Cancer Center
Austin, Texas, United States, 78745
Texas Oncology Bedford
Bedford, Texas, United States, 76022
Texas Oncology at Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Texas Oncology Fort Worth at 12th Avenue
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
The Methodist Hospital System
Houston, Texas, United States, 77030
West Texas Cancer Center
Odessa, Texas, United States, 79761
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States, 77479
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
United States, Washington
MultiCare Auburn Medical Center
Auburn, Washington, United States, 98001
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States, 98335
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States, 98372
MultiCare Tacoma General Hospital
Tacoma, Washington, United States, 98405
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States, 82001
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H3H 2R9
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
China, Shanghai
Zhongshan Hospital Fudan University
Guangdong Province, Shanghai, China, 200032
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia, 11211
Singapore
National University Hospital Singapore
Singapore, Singapore, 119074
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kathleen Moore NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01414608     History of Changes
Other Study ID Numbers: ANZGOG-0902-GOG-0274
NCI-2011-02978 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ANZGOG-0902/GOG-0274/RTOG-1174
CDR0000706698
GOG-0274
RTOG-1174
ANZGOG-0902
ANZGOG-0902-GOG-0274 ( Other Identifier: NRG Oncology )
ANZGOG-0902-GOG-0274 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2011
First Posted: August 11, 2011
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Infertility
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Genital Diseases, Male
Neoplasms, Complex and Mixed
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action