A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer
OBJECTIVES:
- Compare the relapse-free survival in patients with stage I or II endometrial cancer
treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total
abdominal hysterectomy and bilateral salpingo-oophorectomy.
- Compare the patterns of recurrence and the acute and late toxicity profiles associated
with these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.
- Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a
week for 5.5 weeks.
- Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I
concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of
radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over
2-4 hours on days 56, 84, 112, and 140.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Kathryn M. Greven, MD
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CDR0000068040
NCT00006027
August 2000
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Community Hospital of Los Gatos | Los Gatos, California 95032 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Brookview Research, Inc. | Nashville, Tennessee 37203 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
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 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cooper University Hospital | Camden, New Jersey 08103 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |