NCT01715363终止2 期
Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Clinical tolerance of immediate preoperative chemotherapy
研究概览
简要总结
The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions
- •primitive tumor must be operate
- •patient age between 18 and 70
- •OMS status performance < 2
- •life expectancy > 12 weeks
- •hematologic function : PNN >/= 1.5x10^9/L, platelets >/= 100x10^9/L
- •hepatic function : bilirubin </= 1.5xLSN, AST and ALT </= 3xLSN, alcalin phosphatasis </= 3xLSN
- •plasmatimic creatin </= 1.25xLSN
- •No previous chemotherapy or pelvic radiotherapy
- •men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men
排除标准
- •nonmetastatic forms
- •Colorectal tumor which requires preoperative radiotherapy
- •nonmeasurable metastasis based on RECIST criteria
- •previous chemotherapy for colorectal cancer
- •previous irradiation of the primitive tumour
- •specific indication against the treatment studied
- •Patient considered as inoperable for physiological or carcinologic reasons
- •Pregnant or breast feeding women
研究组 & 干预措施
FOLFOX + surgery + FOLFOX
Experimental
- Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery
- resection of the colorectal tumor during surgery
- Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)
干预措施: Oxaliplatin (Drug)
FOLFOX + surgery + FOLFOX
Experimental
- Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery
- resection of the colorectal tumor during surgery
- Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)
干预措施: Folinic Acid (Drug)
FOLFOX + surgery + FOLFOX
Experimental
- Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery
- resection of the colorectal tumor during surgery
- Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)
干预措施: Fluorouracile (Drug)
结局指标
主要结局
Clinical tolerance of immediate preoperative chemotherapy
时间窗: Assess up to 30 days after surgery
Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality. All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
次要结局
未报告次要终点
研究者
研究点 (1)
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