ACTRN12606000300572已完成3 期
An open, randomised controlled phase III clinical trial investigating whether the addition of tamoxifen to cisplatin (or carboplatin) and cyclophosphamide for the treatment of International Federation of Gynecology and Obstetrics (FIGO) Stage III and IV advanced carcinoma of the ovary improves time to disease progression
The Cancer Council Victoria0 个研究点目标入组 230 人开始时间: 1994年12月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- Female
入选标准
- •Histologically confirmed advanced epithelial carcinoma of the ovary (FIGO Stage III or IV), excluding tumours of low malignant potential. ECOG performance status 0 to 3. No previous systemic chemotherapy or radiotherapy. No history of other malignancies apart from skin cancer or adequately treated carcinoma-in-situ of the cervix. Adequate bone marrow function, viz. white cell count > 4.0 x 10^9/L, platelets > 100 x 10^9/L. Adequate renal function, viz. serum creatinine < 0.15 mmol/L (for patients to be given cisplatin) or creatinine clearance > 0.4 ml/sec (for patients to be given carboplatin). Suitable for follow-up- Informed consent, according to the Ethics Committee requirements of each institution, must be obtained. Surgery must have been performed within the previous 6 weeks. The dimensions of the largest residual tumour deposit(s) must at the conclusion of primary surgery must be known.
排除标准
- •No exclusion criteria
研究者
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