Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126256
Recruitment Status : Completed
First Posted : August 3, 2005
Last Update Posted : August 13, 2015
Fondation Francaise de Cancerologie Digestive
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Metastasis Drug: 5-fluorouracil Drug: leucovorin Drug: irinotecan Drug: oxaliplatin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05
Study Start Date : February 2002
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Overall survival
  2. Secondary surgery
  3. Response rate
  4. Progression-free survival after the first and the third line of chemotherapy
  5. Safety
  6. Quality of life
  7. Costs

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00126256     History of Changes
Other Study ID Numbers: FFCD 2000 - 05
CET 815
First Posted: August 3, 2005    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 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
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs