Spots Global Cancer Trial Database for Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
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Trial Identification
Brief Title: Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
Official Title: WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III
Study ID: NCT00002493
Study Description
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. It is not yet known which treatment regimen is more effective for endometrial cancer. PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in treating patients who have advanced endometrial cancer.
Detailed Description: OBJECTIVES: I. Compare overall survival, progression-free interval, and patterns of failure of maximally debulked patients with stage III/IV endometrial carcinoma treated with whole-abdominal irradiation vs. doxorubicin/cisplatin. II. Compare the incidence and type of acute and late adverse events observed with these two treatment regimens. III. Compare changes in fatigue, elimination, and neurologic impairment that impact on quality of life in patients treated with these two regimens. IV. Assess the difference in short-term versus long-term impact on quality of life between the two treatment groups. V. Compare quality-of-life outcomes over time between these two treatment groups. OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-abdominal irradiation using equipment with photon energies ranging from 6 to 25 MV. Arm II: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875. PROJECTED ACCRUAL: It is anticipated that 355 patients will be entered over 7.4 years.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Women's Cancer Center, Palo Alto, California, United States
Stanford University Medical Center, Stanford, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
Cancer Center of Albany Medical Center, Albany, New York, 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
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
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Brookview Research, Inc., Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Baptist Cancer Institute, Memphis, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
Tacoma General Hospital, Tacoma, Washington, United States
Contact Details
Name: Marcus E. Randall, MD
Affiliation: Indiana University Melvin and Bren Simon Cancer Center
Role: STUDY_CHAIR
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