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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Terminated
CT.gov ID
NCT01715363
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
23
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 >/= 1.5x109/L, platelets >/= 100x109/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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Gustave Roussy Villejuif Val de Marne France 94805

Sponsors and Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01715363
Other Study ID Numbers:
  • 2011-003446-41
  • 2010/1676
First Posted:
Oct 26, 2012
Last Update Posted:
Feb 10, 2016
Last Verified:
Feb 1, 2016
Additional relevant MeSH terms:
Colorectal Neoplasms
Leucovorin
Folic Acid
Oxaliplatin
Levoleucovorin

Study Results

No Results Posted as of Feb 10, 2016