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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Federation Francophone de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 5, 2000
Last updated: February 3, 2009
Last verified: September 2000

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 Intervention Phase
Colorectal Cancer Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 1998
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.


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
  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 identifier: 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
  More Information

Publications: Identifier: NCT00005979     History of Changes
Other Study ID Numbers: CDR0000067967
Study First Received: July 5, 2000
Last Updated: February 3, 2009

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 processed this record on July 19, 2017