Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pathologic response rate
研究概览
简要总结
To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.
详细描述
Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy.
Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.
Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age
- •histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •bone marrow reserve (neutrophil count >1500 cells per μL,platelet count >100 000 per μL) count
- •hepatic function (serum bilirubin <2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
- •renal function with a creatinine clearance >60ml/min
排除标准
- •metastatic disease
- •serious or uncontrolled concurrent medical illness
- •pregnancy
- •history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
- •non-transitional cell bladder cancer
- •creatinine clearance <60ml/min
研究组 & 干预措施
gemcitabine plus cisplatin
gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied
干预措施: gemcitabine plus cisplatin (Drug)
结局指标
主要结局
pathologic response rate
时间窗: at time of surgery
evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy
次要结局
- safety, number of participants with adverse events and grade of adverse events(adverse events will be evaluated after every 6 months)
研究者
Johannes Meran
Prof. Dr.Johannes Meran
Barmherzige Brüder Vienna