Clinical trial · Interventional
Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
NCT00002976CI-TRIAL-00010010terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conjugated estrogens | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- RESULTBarakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS; Gynecologic Oncology Group Study. Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Feb 1;24(4):587-92. doi: 10.1200/JCO.2005.02.8464. PMID 16446331