Endometrial Cancer
Conditions
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma
Brief summary
RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.
Detailed description
OBJECTIVES: * Determine the effect of estrogen replacement therapy on recurrence free and overall survival in women with a history of stage I or II endometrial adenocarcinoma. OUTLINE: This is a randomized, double blind study. Patients are stratified according to stage of endometrial cancer (IA vs IB/IC vs II). Patients are randomized to one of two treatment arms: * Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years. * Arm II: Patients receive oral placebo daily for 3 years. Patients are followed every 6 months for 3 years and then annually for 2 years. PROJECTED ACCRUAL: Approximately 2,108 patients will be accrued for this study.
Interventions
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
SWOG Cancer Research Network
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed grade I, II or III endometrial adenocarcinoma (endometrioid, villoglandular, mucinous, adenosquamous, papillary serous, clear cell, or not otherwise specified) * Must have had total hysterectomy and bilateral salpingo-oophorectomy within past 20 weeks * Surgical stage IA, IB, IC, IIA (occult), or IIB (occult) disease * Must have had normal mammogram, or a negative breast biopsy after an abnormal mammogram, within past year PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 3 times normal * No acute liver disease Renal: * Not specified Cardiovascular: * No prior thromboembolic disease Other: * No prior or current carcinoma of the breast * No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent hormonal therapy Radiotherapy: * Not specified Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No prior cancer treatment that would preclude study therapy * Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
Countries
United States
Outcome results
None listed