Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer (PRIMM)

February 9, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val de Marne
      • Villejuif, Val de Marne, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Oxaliplatin
Drug: Folinic Acid
Drug: Fluorouracile

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Diane GOERE, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-003446-41
  • 2010/1676 (Other Identifier: Institut Gustave Roussy)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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