Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

NCT00091312 | Unknown Phase 3

• 4 other identifiers: CDR0000387797FFCD-EORTC-40012EORTC-40012PETACC-4
• Study Type: interventional
• Target: 1,976
• Locations: 6 countries
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer. PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; adenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

• Disease-free survival at 5 years

Secondary Outcomes (3)

• Overall survival at 8 years

• Tolerability

• Correlation of clinical, histological, and biological prognostic factors with outcome

Interventions

FOLFIRI regimen DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon * Stage II disease (pT3, N0 or pT4, N0) * Penetration of the subserosa or serosa * No lymph node metastases * At least 12 lymph nodes analyzed * More than 1 synchronous primary colon tumor allowed * Staging determined for the more advanced tumor * Curative radical resection within the past 2-8 weeks required * Proximal, distal, and radical margins must be free of tumor (R0 resection) * No rectal tumors * Gross distal margin of the primary tumor must lie above the peritoneal reflection * No known familial adenomatous polyposis * No hereditary nonpolyposis colorectal cancer * No distant metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * Bilirubin \< 1.25 times upper limit of normal (ULN) * No known Gilbert's syndrome Renal * Creatinine \< 1.25 times ULN Cardiovascular * No severe or uncontrolled coronary disease * No severe heart failure * No uncontrolled arterial hypertension * No myocardial infarction within the past year * No cerebral vascular accident within the past year * Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy\* NOTE: \*Aspirin is not considered proper anticoagulation Gastrointestinal * No Gardner's syndrome * No Turcot's syndrome * No Crohn's disease * No ulcerative colitis Other * No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No other serious disease * No contraindication to any study drugs * No known allergy to leucovorin calcium * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 6 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics Other * No other concurrent anticancer therapy * No concurrent vitamin supplements containing folic acid

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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (9)

National Cancer Institute - Cairo

Cairo, Egypt

Location

Centre Hospitalier Universitaire Ambroise Pare - Boulogne

Boulogne-Billancourt, F-92104, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Azienda Ospedaliero Careggi

Florence, 50139, Italy

Location

Universita Degli Studi di Florence - Policlinico di Careggi

Florence, 50139, Italy

Location

Instituto Portugues de Oncologia Centro do Porto, S. A.

Porto, 4200-072, Portugal

Location

Hospital Universitario de Elche

Elche Alicante, E-03203, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin; Chemotherapy, Adjuvant

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; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Laurent Bedenne, MD

  Hopital Du Bocage

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: June 1, 2004
• Last Updated: February 9, 2009

Record last verified: 2006-12

Locations

ES (1); PT (1); EG (1); FR (2); DE (1); IT (3)