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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Aaron H. Wolfson, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
United States: Federal Government
CDR0000063303
NCT00002546
December 1993
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
Women's Cancer Center - Los Gatos | Los Gatos, California 95032 |
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
CCOP - Evanston | Evanston, Illinois 60201 |
Hinsdale, Illinois 60521 | |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Cancer Center at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Gynecologic Oncology Network | Greenville, North Carolina 27858 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Abramson Cancer Center at the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Southeast Gynecologic Oncology Associates | Knoxville, Tennessee 37917 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus | Burlington, Vermont 05401 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |