Endometrial Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Prevention
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