Spots Global Cancer Trial Database for Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
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Trial Identification
Brief Title: Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
Official Title: A Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy (AHWAR) Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I, II, III, or IV Carcinosarcoma (CS) of The Uterus
Study ID: NCT00002546
Conditions
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 whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.
Detailed Description: OBJECTIVES: * Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin. * Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks. * Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
Women's Cancer Center - Los Gatos, Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
, Hinsdale, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Gynecologic Oncology Network, Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington, United States
Pretoria Academic Hospital, Pretoria, , South Africa
Contact Details
Name: Aaron H. Wolfson, MD
Affiliation: University of Miami Sylvester Comprehensive Cancer Center
Role: STUDY_CHAIR
Name: Higinia R. Cardenes, MD, PhD
Affiliation: Indiana University Melvin and Bren Simon Cancer Center
Role: STUDY_CHAIR
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