Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia.
PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||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|
|Study Start Date:||November 1998|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003179
Show 31 Study Locations
|Study Chair:||John P. Curtin, MD||Memorial Sloan Kettering Cancer Center.|
|Investigator:||George L. Mutter, MD||Dana-Farber/Brigham and Women's Cancer Center|
|Investigator:||Francisco A. R. Garcia, MD, MPH||University of Arizona|
|Investigator:||Richard Zaino, MD||Milton S. Hershey Medical Center|