EUCTR2007-000357-54-FR进行中(未招募)不适用
Chemotherapy of first line reinforced for cancers of the colonist and the rectum with hepatic and/or pulmonary metastases potentially résécables: Strong association FOLFIRI and ERBITUX - ERBIFORT
niversityHospitalGrenoble0 个研究点开始时间: 2007年6月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Will be proposed for the study the subjects answering each following criterion: Index of performance WHO 18 years
- •Rectal Adenocarcinomist colic or with hepatic metastases (synchronous or métachrones) not résécables of start: - Less than 8 hepatic metastases and less than 6 hepatic segments reached - Not more than 2 extra-hepatic metastatic sites potentially résécables
- •Visceral metastases potentially résécables if tumoral regression after chemotherapy
- •Cancer (primitive and/or metastases) histologically proven
- •Immediate Non-resecability reserve by a hépato-biliary surgeon at a multidisciplinary conciliation meeting
- •At least a measurable supra-centimetric metastasis by helicoid tomodensitometry and/or IRM
- •Life expectancy 3 months
- •Bilirubine 1500/mm3, plates 100 000/mm3
- •Creatinin 60 ml/min
- •Rate of Prothrombine 70 %
- •Enlightened assent
- •Possible follow-up
- •Nobody affiliated with the social security or profit of such a mode
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •could not be included the subjects answering at least one of the following criteria:
- •More than 6 hepatic segments reached of metastases
- •More than 2 extra-hepatic metastatic sites or not obvious resecability of extra-hepatic metastases
- •Cerebral metastases or carcinomatous meningitis of cancer colorectal
- •Carcinose péritonéale or c?liaque ganglionic extension
- •Osseous metastases?
- •Antecedents of another malignant tumour (except cutaneous cancers basocellulaires or in situ cancers of the uterine collar)
- •Co-morbidity considered to be too important or contra-indicating chemotherapy (or the surgical résection of metastases (for example: angor unstable, symptomatic cardiac insufficiency)
- •Pregnant woman parturient, mother who nurses
- •Antecedents of anti-cancer chemotherapy (except an auxiliary chemotherapy if it has been finished for at least 3 months)Inclusion in another therapeutic test requiring the realization of other treatments that those of this study
- •Nobody private of freedom by court order or administrative, anybody being the subject of a legal protection measure,
研究者
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