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
medroxyprogesterone
Urogenital Diseases+9
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Prevention Study
Summary
Study start date: November 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.360 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed atypical endometrial hyperplasia with recommended treatment with either: An immediate hysterectomy (Part A) OR A three-month delay prior to hysterectomy and a randomized choice of treatment with oral medroxyprogesterone acetate (Provera) or medroxyprogesterone acetate suspension (Depo-Provera) during the 3 months (Part B with arms I and II) Diagnosed by dilation and curettage, Novak curettage, Vabra aspirate or Pipelle endometrial biopsy No recognized endometrial carcinoma Must not be considered inoperable PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2 times normal Cardiovascular No prior thrombophlebitis or thromboembolic phenomena No prior cerebrovascular disorders Other: No prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the uterine cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 31 locations
Community Hospital of Los Gatos
Los Gatos, United StatesChao Family Comprehensive Cancer Center
Orange, United StatesWalter Reed Army Medical Center
Washington D.C., United States