A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma
OBJECTIVES:
- Compare survival and progression-free survival in patients with stage III endometrial
carcinoma treated with tumor volume-directed pelvic radiotherapy with or without
paraaortic radiotherapy followed by cisplatin and doxorubicin with or without
paclitaxel.
- Compare short and long-term toxic effects of these treatment regimens in this patient
population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
radiotherapy field (pelvic vs extended field).
Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy
with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16
weeks after surgery.
Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy
treatment arms.
- Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by
cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SC) or pegfilgrastim on days 2-11.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3
hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12.
Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this
study within 5.2 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Howard D. Homesley, MD
Study Chair
Gynecologic Oncology Network
United States: Federal Government
CDR0000068020
NCT00006011
July 2000
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
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 |
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 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
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 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
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 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
CCOP - Evanston | Evanston, Illinois 60201 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
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 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
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 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
Cooper University Hospital | Camden, New Jersey 08103 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
Arthur G. James Cancer Hospital at Ohio State University | Columbus, Ohio 43210-1240 |
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
Gynecologic Oncology Network | Nashville, Tennessee 37203 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Abramson Cancer Center of the University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104-4283 |
Women's Cancer Center at Community Hospital of Los Gatos | Los Gatos, California 95032 |
Multicare Medical Center | Tacoma, Washington 98405 |