ACTRN12610000845033已完成3 期
Prospective, randomized phase III study to compare survival between two intensified treatment groups (Methotrexate/Vinblastine/Adriamycin/Cisplatin (MVAC) vs. Gemcitabine/Cisplatin) in patients with inoperable or recurrent urothelial cancer
Hellenic Cooperative Oncology Group0 个研究点目标入组 206 人开始时间: 2010年10月7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
- 206
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Histologically confirmed inoperable or recurrent transitional cell advanced urothelial cancer
- •2. Age of >18 years
- •3. Life expectancy > 3 months
- •4. No prior chemotherapy for advanced disease is allowed
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1
- •6. Creatinine clearance > 50 ml/min (Cockroft Formula)
- •7. Absolute Neutrophil Count (ANC)>= 1,500 /Microlitre (microL), platelets>= 100,000 /microL, bilirubin and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2N
- •8. Absence of cardiac failure. Patients previously treated with adriamycin are excluded from the study. Patients with cardiac disease should demonstrate a baseline left ventricular ejection fraction (LVEF) >50%
- •9. Signed Informed Consent
排除标准
- •1.Other histology types of urothelial cancer. Mixed histology types mainly of transitional cell cancer are allowed.
- •2.History of other neoplasm within the 5 last years except for radically excised basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix.
- •3.Prior adjuvant or neo-adjuvant chemotherapy containing adriamycin. Patients who received adjuvant or neo-adjuvant chemotherapy with Gemcitabine/Cisplatin or Gemcitabine/Carboplatin within the last 12 months are excluded.
- •4.Any active infection or other uncontrolled underlying condition (infection, cardiac arrythmia, diabetes mellitus)
- •5.Women of reproductive age should obtain a negative pregnancy test. All sexually active patients should take efficient contraceptive measures.
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