NL-OMON35127已完成2 期
A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY - RECARDO
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 18 years and above.
- •2. Histologically proven hormone refractory prostate adenocarcinoma.
- •3. PSA and/or clinical response on prior docetaxel-based chemotherapy with a progression free interval of over 3 months.
- •4. Last PSA value * 5 ng/ml within 2 weeks prior to registration (HYBRITECH equivalent)
- •5. Patients without surgical castration must continue on LHRH agonist therapy
- •6. ECOG performance status * 2
- •7. Gleason score 8-10
- •8. Adequate haematological, liver and renal function.
排除标准
- •1. More than 1 line of chemotherapy.
- •2. Prior platinum chemotherapy.
- •3. Radiotherapy within 2 weeks prior to treatment start.
- •4. Uncontrolled hypercalcemia.
- •5. Evidence of symptomatic brain and leptomeningeal metastatic disease.
- •6. Previous or concurrent malignancies at other sites (except basal squamous cell carcinoma of the skin).
研究者
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