NCT00403624已完成1 期
Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer
适应症
相关药物
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
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
- •The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- •Main criteria are listed hereafter:
- •Inclusion Criteria:
- •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
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