NCT01103544已完成不适用
Usage of Vinflunine i.v. (JAVLOR®) for the Treatment of Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium in Adult Patients After Failure of a Cisplatinum-containing Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
研究概览
简要总结
Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Legally competent male and female patients
- •Advanced or metastatic transitional cell carcinoma of the urothelium
- •Failure of a prior Cisplatinum-containing treatment
- •Performance Status 0 or 1
- •Signed patient informed consent
排除标准
- •Missing signed patient informed consent
- •Performance Status 2 or higher
- •Life expectancy < 2 months
- •Brain metastases
- •Creatinine-clearance < 20 ml/min
- •Child-Pugh-stadium C
- •Prothrombin time < 50%
- •Bilirubin > 5 x ULN
- •Transaminases > 6 x ULN
- •Gamma-Glutamyl-transferase > 15 x ULN
- •Pregnant or breast-feeding women
- •Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids
- •Recent (within the last 2 weeks) or current severe infections
- •Baseline ANC < 1,500/mm3 or platelets < 100,000/mm3
- •Patients being institutionalised due to court/regulatory order
结局指标
主要结局
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
时间窗: 9 months after LPI
次要结局
- Explorative assessment of Overall Response Rate (ORR)(9 months after LPI)
- Anti-emetic comedication(9 months after LPI)
- Anti-obstipative diet / comedication(9 months after LPI)
- General well-being / quality of life of the patients (patient questionnaire)(9 months after LPI)
- Patients' satisfaction with the treatment (patient questionnaire)(9 months after LPI)
- Physicians' satisfaction with the treatment(9 months after LPI)
- Patients' compliance with regards to the cotreatments (patient questionnaire)(9 months after LPI)
研究者
研究点 (1)
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