Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer

Sanofi0 个研究点目标入组 38 人开始时间: 2001年7月最近更新: 2010年8月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Sanofi
入组人数: 38
主要终点: Tumour response

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Primary objective:

To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

tolerability (toxicity) and time to progression

研究设计

研究类型: Interventional
分配方式: Non Randomized
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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with measurable, histologically proven rectal cancer.
•No history of previous malignancy but adequately treated skin / cervical cancer.
•Adequate haematological, renal and liver function.

排除标准

•No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.

结局指标

主要结局

Tumour response

次要结局

Disease free and Overall survival ; Adverse events

研究者

发起方

Sanofi

申办方类型

Industry

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