SWOG clinical trial number
G0167

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

Closed
Phase
Published
Abbreviated Title
ENDOMETRIAL
Activated
07/15/2001
Participants
NCORP, Members, Surgeons, Pathologists

Research committees

Gynecologic Cancer

Treatment

Depo-Provera® Medroxyprogesterone acetate

Eligibility Criteria Expand/Collapse

Atypical endometrial hyperplasia. GOG Performance Status of 0, 1, or 2. Patients with a diagnosis of atypical endometrial hyperplasia, diagnosed by D&C, Novak curettage, Vabra aspirate or Pipelle endometrial biopsy. Part B only: AEH confirmed on expedited review by Johns Hopkins pathologists. Patients must have adequate hematologic, renal and hepatic function: WBC >/= 3,000, platelets >/= 100,000, granulocytes >/= 1,500, creatinine </= 2, bilirubin </= 1.5 x normal, SGOT and alkaline phosphatase </= 3x normal. Part B only: Patients of child-bearing potential must use appropriate non-hormonal contraception while on study. No recognized endometrial carcinoma. No inoperable patients. No other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy. Non-pregnant, non-nursing. No history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders.

Publication Information Expand/Collapse

2006

Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: A Gynecologic Oncology Group Study

CL Trimble;J Kauderer;R Zaino;S Silverberg;PC Lim;JJ Burke;DS Alberts;J Curtin Cancer 106(4):812-819