Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix
- Conditions
- Cervical Cancer
- Registration Number
- NCT00003078
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known whether receiving radiation therapy plus cisplatin is more effective than receiving radiation therapy plus fluorouracil in treating patients with cancer of the cervix.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage IVA cancer of the cervix.
- Detailed Description
OBJECTIVES: I. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis receiving either radiotherapy alone, or radiotherapy plus weekly cisplatin, or radiotherapy plus prolonged venous infusion (PVI) of fluorouracil. \[Radiotherapy alone regimen closed 8/18/98\] II. Determine the relative toxic effects of radiation therapy plus chemotherapy with either weekly cisplatin or PVI fluorouracil compared to radiation alone. \[Radiotherapy alone regimen closed 8/18/98\] IV. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who smoke at the time of diagnosis versus non-smokers and those who smoke during radiation therapy versus those who quit.
OUTLINE: This is a randomized study. Patients are stratified by stage, performance of para-aortic lymphadenectomy, and brachytherapy method (HDR vs LDR). Prior to treatment patients complete a questionnaire regarding past and present smoking history and exposure to secondhand smoke. In arm I, patients undergo external radiation therapy to the pelvis once daily 5 times a week for 5 weeks. Then, patients receive either low dose rate or high dose rate intracavitary brachytherapy in one or two applications or 5 fractions once or twice a week, respectively. If intracavitary radiation therapy cannot be performed, then shrinking field technique is executed. In addition, patients receive parametrial boost once daily for 3 to 5 days during intracavitary brachytherapy. Concurrently, patients receive IV cisplatin once a week for 5 weeks beginning on day 1 of external radiation therapy and once during the parametrial boost. Patients in arm II receive external radiation therapy and brachytherapy as previously described. \[Arm II closed 8/18/98\] In arm III, patients undergo external radiation therapy as described in arm I. In addition, patients receive prolonged venous infusion (PVI) fluorouracil daily for 5 days during external beam radiation therapy (whole pelvis and parametrial boost). If all 6 courses of cisplatin or fluorouracil cannot be administered during external radiation therapy, then the sixth course of chemotherapy will be given during brachytherapy. Patients are followed every 3 months for the first 2 years, then every 6 months for the next 3 years, then annually until death.
PROJECTED ACCRUAL: This study will accrue a maximum of 870 patients over 66 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 870
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Sooner State
🇺🇸Tulsa, Oklahoma, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Women's Cancer Center
🇺🇸Palo Alto, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
NCIC-Clinical Trials Group
🇨🇦Kingston, Ontario, Canada
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Fred J. Woods Radiation Therapy Center/St. Joseph's Cancer Institute
🇺🇸Tampa, Florida, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Medicine Branch
🇺🇸Bethesda, Maryland, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States