Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial
10 other identifiers
interventional
926
5 countries
326
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2012
Longer than P75 for phase_3
326 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
January 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2021
CompletedResults Posted
Study results publicly available
November 7, 2022
CompletedNovember 7, 2022
October 1, 2022
9.5 years
August 10, 2011
May 24, 2022
October 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival Rate at 5 Years
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 Outcomes (5)
Progression-free Survival Rate at 5 Years
5 years from study randomization
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year
1 year after randomization
Patterns of Disease Recurrence
through study completion an average of 60 months
Radiation Protocol Compliance
Average duration of 7 weeks
Quality of Life for Global Health Status
Baseline and 12 months
Study Arms (2)
Arm I (cisplatin, radiation therapy, brachytherapy)
EXPERIMENTALPatients 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.
Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
EXPERIMENTALPatients 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.
Interventions
Undergo brachytherapy
Given IV
Given IV
Undergo external beam radiation therapy
Given IV
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GOG Foundationlead
- National Cancer Institute (NCI)collaborator
Study Sites (326)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, 85012, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Arizona Oncology Associates-Biltmore Cancer Center
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, 85704, United States
Arizona Oncology Associates-Wilmot
Tucson, Arizona, 85710, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
John Muir Medical Center-Concord Campus
Concord, California, 94520, United States
Sutter Davis Hospital
Davis, California, 95616, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Memorial Medical Center
Modesto, California, 95355, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-San Rafael
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Southwest Oncology PC
Durango, Colorado, 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
University of Connecticut
Farmington, Connecticut, 06030, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, 33136, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Central Georgia Gynecologic Oncology
Macon, Georgia, 31201, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
The Community Hospital
Munster, Indiana, 46321, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky, 40241, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center - Memorial Division
Worcester, Massachusetts, 01605, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
Women's Cancer Care Associates LLC
Albany, New York, 12208, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
New York Hospital Medical Center of Queens
Fresh Meadows, New York, 11365, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Queens Hospital Center
Jamaica, New York, 11432, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Highland Hospital
Rochester, New York, 14620, United States
University of Rochester
Rochester, New York, 14642, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
University of Toledo
Toledo, Ohio, 43614, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Drexel University School of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379, United States
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, 57701, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology - Central Austin Cancer Center
Austin, Texas, 78731, United States
Texas Oncology - South Austin Cancer Center
Austin, Texas, 78745, United States
Texas Oncology Bedford
Bedford, Texas, 76022, United States
Texas Oncology at Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Zhongshan Hospital Fudan University
Guangdong Province, Shanghai Municipality, 200032, China
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211, Saudi Arabia
National University Hospital Singapore
Singapore, 119074, Singapore
Related Publications (2)
Mileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, Bradshaw N, Lee YC, Diamante K, Fyles AW, Small W Jr, Gaffney DK, Khaw P, Brooks S, Thompson JS, Huh WK, Mathews CA, Buck M, Suder A, Lad TE, Barani IJ, Holschneider CH, Van Dyk S, Quinn M, Rischin D, Monk BJ, Stockler MR. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 May;24(5):468-482. doi: 10.1016/S1470-2045(23)00147-X. Epub 2023 Apr 17.
PMID: 37080223DERIVEDGould HJ 3rd, Miller PR, Edenfield S, Sherman KJ, Brady CK, Paul D. Emergency Use of Targeted Osmotic Lysis for the Treatment of a Patient with Aggressive Late-Stage Squamous Cell Carcinoma of the Cervix. Curr Oncol. 2021 Jun 8;28(3):2115-2122. doi: 10.3390/curroncol28030196.
PMID: 34201380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for Wei Deng
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen N Moore
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
January 9, 2012
Primary Completion
July 9, 2021
Study Completion
July 9, 2021
Last Updated
November 7, 2022
Results First Posted
November 7, 2022
Record last verified: 2022-10