cancers of the colonist and the rectum
Conditions
Interventions
Trade Name: CAMPTO®
Product Name: CAMPTO®
Pharmaceutical Form: Solution for iontophoresis
Trade Name: ERBITUX®
Product Name: ERBITUX®
Pharmaceutical Form: Solution for injection
Trade Name: FLUOROUR
Sponsors
UniversityHospitalGrenoble
Eligibility
Sex/Gender
All
Inclusion criteria
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
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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal objective: Rate of tumoral response to the treatment (answers objectify = complete answers and partial answers) Objective secondaries: ;Secondary Objective: Objective 2: Objective rate of resecability 3: Rate of repetition after résection. Objective 4: Survival: without progression, repetition for the réséqués patients and total survival. Objective 5: Reduction in the Objective number of hospitalization 6: Tolerance with the Objective treatment 7: Tolerance with the treatment;Primary end point(s): 1//Critère of principal judgement: Objective RECIST 2//Critères of judgements: Percentage of resecability Objective R0 of metastases 3//Critères of judgements: Percentage of resecability Objective R0 of metastases 4//Critères of judgements: Reliability curve Objective 5//Critères of judgements: A number of days of hospitalization except delivery of chemotherapy Objective 6//Critères of judgements: Criteria NCI-CTC version 2 and rate of stop of treatment due to Objective adverse effect 7//Critères of judgements: Toxicity according to criteria's NCI-CTC version 2 | — |
Countries
France
Outcome results
None listed