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
- 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
- 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
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.
Allocation: Randomized, Primary Purpose: Prevention
John P. Curtin, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|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|