NL-OMON43780已完成2 期
PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER<br> - CHEMORAD-TRIA
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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 64（—）
入选标准
- •All patients with locally advanced (T3-4) and/or node positive bladder cancer (>=N1), who are fit to receive cisplatin-based combination chemotherapy and who are eligible for surgery, may be included in this study. ;
- •- Signed written informed consent
- •- Locally advanced urothelial carcinoma of the bladder (cT3-T4) or any cT-stage with cytologically or histologically proven node positive urothelial carcinoma (or positive FDG/PET-CT-scan with suspect lymph nodes, including supraregional retroperitoneal lymph nodes below the diaphragm.
- •- Renal function: Creatinin clearance >= 50 mL/min (calculated) and serum creatinin <=1.5 x UNL.
- •- In case of hydronefrosis: relative function of the hydronefrotic kidney should be at least 30%.
- •- Karnofsky performance >=70
排除标准
- •-Distant metastases (M+)
- •-Severe bladder symptoms (necessitating cystectomy).
- •-Bilateral hydronefrosis.
- •-Persisting hydronephrosis after induction chemotherapy (necessitating cystectomy). A temporary nefrostomy is indicated during chemotherapy.
- •-Previous radiation therapy on pelvic region
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