Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Estrogens; Estrogens, Conjugated (USP)

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