Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

Phase 2

Terminated

• Conditions: Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
• Interventions: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: Fluorouracile

• Registration Number: NCT01715363
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFOX + surgery + FOLFOX	Oxaliplatin	* 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)
FOLFOX + surgery + FOLFOX	Fluorouracile	* 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)
FOLFOX + surgery + FOLFOX	Folinic Acid	* 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)

Primary Outcome Measures

Name	Time	Method
Clinical tolerance of immediate preoperative chemotherapy	Assess up to 30 days after surgery	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

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, Val de Marne, France