A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Primary, histologically confirmed Grades 1, 2, and 3 endometrial adenocarcinoma (endometrioid, villoglandular, mucinous, adenosquamous, papillary serous, clear cell, and N.O.S.). Must have had a total hysterectomy, bilateral salpingo-oophorectomy, and be found to be surgical stage IA, IB, IC, IIA (occult) and IIB (occult). Recovered from the effects of recent surgery and entered on the study within 20 weeks from time of surgery. Adequate hepatic function: bilirubin less than or equal to 1.5 x normal and SGOT less than or equal to 3 x normal. Must have had one normal mammogram, or negative breast biopsy after an abnormal mammogram, within one year prior to study entry. Patients entered onto either GOG #Lap-1 or GOG #Lap-2 are eligible to enter this protocol within 20 weeks from the time of surgery. No known or suspected carcinoma of the breast. No past history of breast malignancy. No acute liver disease. No patients receiving any form of sex hormonal therapy. No history of thromboembolic disease. 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. Patients with non-melanoma skin cancer are eligible regardless of the time of diagnosis.