NCT00002976终止3 期
A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,108
- 试验地点
- 295
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 3 times normal
- •No acute liver disease
- •Not specified
- •Cardiovascular:
- •No prior thromboembolic disease
- •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
- •See Disease Characteristics
- •Recovered from prior surgery
- •No prior cancer treatment that would preclude study therapy
- •Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
排除标准
- 未提供
研究者
研究点 (295)
Loading locations...
相似试验
终止
2 期
Estrogen Replacement in Anorexia NervosaAnorexia NervosaNCT03172533University of Erlangen-Nürnberg Medical School11
Unknown
3 期
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast CancerBreast CancerNCT00003418International Collaborative Cancer Group4,400
已完成
2 期
Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal WomenSexual Dysfunction, PhysiologicalNCT06308614Estetra82
已完成
3 期
Heart and Estrogen-Progestin Replacement Study (HERS)Coronary Heart DiseaseNCT00319566University of California, San Francisco2,430
Unknown
4 期
Multi-centre Clinical Trial on Hormone Replacement Treatment in ChinaMenopausal SyndromeBreast CancerOsteoporosisCardiovascular DiseaseNCT01698164Peking Union Medical College Hospital1,200