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Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

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ClinicalTrials.gov Identifier: NCT00005979
Recruitment Status : Unknown
Verified September 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 4, 2009
Federation Francophone de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 3

Detailed Description:


  • Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence.
  • Compare toxicities of these regimens in these patients.
  • Compare quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
  • Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I.

Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.

Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence
Study Start Date : February 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days
  • No metastatic disease
  • Node positive

    • No more than 4 nodes affected (Tx, N2, M0) AND/OR
    • N1 or N2 with perforation and/or occlusion
  • No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy
  • No prior inflammatory disease of the intestine



  • 18 to 75

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • SGOT and SGPT less than 3 times ULN
  • Alkaline phosphatase less than 3 times ULN


  • Not specified


  • No myocardial infarction within past 6 months
  • No insufficient cardiac function


  • No other serious medical illness
  • No active infection
  • No other malignancy except skin cancer or carcinoma in situ of the cervix
  • No psychological or social condition that would preclude study
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior extensive intestinal resection

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 ClinicalTrials.gov identifier (NCT number): NCT00005979

Centre Paul Papin
Angers, France, 49036
Clinique St. Etienne
Bayonne, France, 64100
Institut Bergonie
Bordeaux, France, 33076
Centre Hospitalier de Fleyriat
Bourg-En-Bresse, France, 01012
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin-Jallieu, France, 38300
Centre Hospitalier General
Brive, France, 19101
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Faculte de Medecine
Dijon, France, 21033
Hopital Du Bocage
Dijon, France, 21034
Centre Hospitalier Maie Madeleine
Forbach, France, 57600
Centre Leon Berard
Lyon, France, 69008
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Institut Jean Godinot
Reims, France, 51056
St Joseph's Medical Center
Reims, France, 51056
Centre Hospitalier Universitaire
Reims, France, 51092
Centre Eugene Marquis
Rennes, France, 35064
Hopital Charles Nicolle
Rouen, France, 76031
Centre Rene Huguenin
Saint Cloud, France, 92210
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Centre Hospitalier de Tarbes
Tarbes, France, 65013
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Valence
Valence, France, 26000
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Centre Hospitalier P. Chubert
Vannes, France, 56260
Centre Hospitalier Regionale de Vichy
Vichy, France, 03201
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Study Chair: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
Study Chair: Jean Faivre Federation Francophone de Cancerologie Digestive

ClinicalTrials.gov Identifier: NCT00005979     History of Changes
Other Study ID Numbers: CDR0000067967
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: September 2000

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
adenocarcinoma of the colon

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