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Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer

This study has been completed.
Fondation Francaise de Cancerologie Digestive
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: August 2, 2005
Last updated: August 11, 2015
Last verified: August 2015
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
Drug: 5-fluorouracil
Drug: leucovorin
Drug: irinotecan
Drug: oxaliplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00126256

Institut Gustave-Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Fondation Francaise de Cancerologie Digestive
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00126256     History of Changes
Other Study ID Numbers: FFCD 2000 - 05
CET 815
Study First Received: August 2, 2005
Last Updated: August 11, 2015

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on April 27, 2017