Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality

Official Title
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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

Conditions
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Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Folinic Acid
* Drug: Fluorouracile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFOX + surgery + FOLFOX<br>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) | Drug: Oxaliplatin<br> <br> Drug: Folinic Acid<br> <br> Drug: Fluorouracile<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical tolerance of immediate preoperative chemotherapy | 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 | Assess up to 30 days after surgery |