A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera
OBJECTIVES:
- Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients
diagnosed at initial biopsy to have complex atypical hyperplasia.
- Compare the histologic response rates in patients with atypical endometrial hyperplasia
treated with oral medroxyprogesterone acetate (Provera) vs intramuscular
medroxyprogesterone acetate suspension (Depo-Provera) .
OUTLINE: This is a randomized, two-part study.
- Part A: Patients undergo immediate hysterectomy.
- Part B: Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for
3 months.
- Arm II: Patients receive medroxyprogesterone acetate suspension (Depo- Provera)
intramuscularly once monthly for 3 months (days 1, 31, and 62).
Patients undergo hysterectomy at the end of the third month.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A minimum of 360 patients for part A and 140 patients (70 per arm) for
part B will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Prevention
John P. Curtin, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000065999
NCT00003179
November 1998
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
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 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
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 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |