NCT00259363终止1 期
Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Phase I : Maximum Tolerated Dose & Recommended Dose
研究概览
简要总结
- Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
- Phase II: To determine the treatment efficacy according to response rates from phase I.
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 80 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:
- •ECOG: 0-2
- •Histological proved rectal adenocarcinoma
- •No chemotherapy treatment on the previous 6 months before inclusion.
- •No previous pelvic radiotherapy treatment
排除标准
- •Important Biological abnormality (renal, hepatic and/or hematological)
- •Intestinal occlusion or subocclusion
- •Peripheral neuropathy
- •Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
- •Participation in other trials on the previous 4 months.
结局指标
主要结局
Phase I : Maximum Tolerated Dose & Recommended Dose
时间窗: Days 1, 15, 29
Phase II : Response and resectability rate.
时间窗: 6 cycles in 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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