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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01715363
First received: October 24, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
Drug: Oxaliplatin
Drug: Folinic Acid
Drug: Fluorouracile
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Clinical tolerance of immediate preoperative chemotherapy [ Time Frame: Assess up to 30 days after surgery ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715363

Contacts
Contact: Diane GOERE, MD +33 1 42 11 54 41 diane.goere@igr.fr
Contact: Valérie BOIGE, MD +33 1 42 11 43 11 valerie.boige@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Diane GOERE, MD    +33 1 42 11 54 41    diane.goere@igr.fr   
Principal Investigator: Diane GOERE, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Diane GOERE, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01715363     History of Changes
Other Study ID Numbers: 2011-003446-41, 2010/1676
Study First Received: October 24, 2012
Last Updated: October 25, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Leucovorin
Folic Acid
Levoleucovorin
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Hematinics
Hematologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014