Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fondation Francaise de Cancerologie Digestive
Sanofi
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00126256
First received: August 2, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Metastasis
Drug: 5-fluorouracil
Drug: leucovorin
Drug: irinotecan
Drug: oxaliplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up

Secondary Outcome Measures:
  • Overall survival
  • Secondary surgery
  • Response rate
  • Progression-free survival after the first and the third line of chemotherapy
  • Safety
  • Quality of life
  • Costs

Estimated Enrollment: 570
Study Start Date: February 2002
Estimated Study Completion Date: February 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal adenocarcinoma
  • Unresectable metastasis
  • Bidimensionally measurable disease (World Health Organization [WHO] criteria)
  • WHO performance status of 2 or less
  • Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre)
  • Adequate renal function (serum creatinine, less than 125 micromol per liter)
  • Adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
  • No previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion
  • Signed written inform consent
  • Quality of life questionnaire (QLQ C-30) filled out

Exclusion Criteria:

  • Pregnant or breast – feeding women
  • Impossibility of regular follow-up for psychological, social or geographical reason
  • Severe cardiac, respiratory, renal or hepatic failure
  • Active coronary heart disease
  • Patients with a history of a psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study
  • Central nervous system metastases
  • Past history of second malignancies
  • Another investigational drug
  • Chronic inflammatory bowel disease
  • Previous chemotherapy with irinotecan or oxaliplatin based regimens
  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: NCT00126256

Contacts
Contact: Michel Ducreux, Pr 00 33 014-211-4308 ducreux@igr.fr
Contact: Jean-Pierre F Pignon, MD, PhD 00 33 014-211-4565 jppignon@igr.fr

Locations
France
Institut Gustave-Roussy Recruiting
Villejuif, France, 94805
Contact: Michel Ducreux, Pr    00 33 014-211-4308    ducreux@igr.fr   
Contact: Jean-Pierre F Pignon, MD, PhD    00 33 014-211-4565    jppignon@igr.fr   
Principal Investigator: Michel Ducreux, Pr         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Fondation Francaise de Cancerologie Digestive
Sanofi
Investigators
Principal Investigator: Michel Ducreux, Pr Gustave Roussy, Cancer Campus, Grand Paris
Study Director: Jean-Pierre F Pignon, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided by Gustave Roussy, Cancer Campus, Grand Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00126256     History of Changes
Other Study ID Numbers: FFCD 2000 – 05, CET 815
Study First Received: August 2, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Colorectal cancer
metastatic
chemotherapy
randomized trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014