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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

Conditions
cancers of the colonist and the rectum
Registration Number
EUCTR2007-000357-54-FR
Lead Sponsor
niversityHospitalGrenoble
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

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

Exclusion Criteria

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,

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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