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

NCT00005979 | Completed Phase 3 DMC

• 4 other identifiers: CDR0000067967FRE-FNCLCC-ACCORD-2FFCD-9802EU-20014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 30

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.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; adenocarcinoma of the colon

Interventions

FOLFIRI regimen DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * 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 Renal: * Not specified Cardiovascular: * No myocardial infarction within past 6 months * No insufficient cardiac function Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics * No prior extensive intestinal resection

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead
• Federation Francophone de Cancerologie Digestive: collaborator

Study Sites (30)

Centre Paul Papin

Angers, 49036, France

Location

Clinique St. Etienne

Bayonne, 64100, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Hospitalier de Fleyriat

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier de Bourgoin - Jallieu

Bourgoin, 38300, France

Location

Centre Hospitalier General

Brivé, 19101, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Faculte de Medecine

Dijon, 21033, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre Hospitalier Maie Madeleine

Forbach, 57600, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

St Joseph's Medical Center

Reims, 51056, France

Location

Centre Hospitalier Universitaire

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Centre Hospitalier de Tarbes

Tarbes, 65013, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Valence

Valence, 26000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Centre Hospitalier P. Chubert

Vannes, 56260, France

Location

Centre Hospitalier Regionale de Vichy

Vichy, 03201, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (2)

• Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.

  PMID: 19179549 RESULT

• Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17.

  PMID: 17510208 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Marc Ychou, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

• Jean Faivre

  Federation Francophone de Cancerologie Digestive

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: July 22, 1998
• Primary Completion: September 26, 2005
• Study Completion: September 1, 2007
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

FR (30)