Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-06-30

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOX + surgery + FOLFOX

* 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)

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

Folinic Acid

Intervention Type DRUG

Fluorouracile

Intervention Type DRUG

Interventions

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Oxaliplatin

Intervention Type DRUG

Folinic Acid

Intervention Type DRUG

Fluorouracile

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No