High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

NCT00004150 | Completed Phase 3

• 5 other identifiers: CDR0000067383PETACC-2EORTC-40963FFCD-PETACC-2GETTD-PETACC-2
• Study Type: interventional
• Target: N/A
• Locations: 6 countries
• Sites: 85

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer. PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; adenocarcinoma of the colon; mucinous adenocarcinoma of the colon

Interventions

fluorouracil DRUG

leucovorin calcium DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon * Must have had curative radical resection within 56 days prior to study * No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No severe coronary heart disease * No New York Heart Association class III or IV heart failure Other: * No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled infection * No other severe disease * No known allergy to leucovorin calcium * No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis * No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer) * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for colon cancer Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for colon cancer Surgery: * See Disease Characteristics Other: * No other concurrent systemic anticancer therapy

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

Sponsors & Collaborators

• Robert Roessle Klinik: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Federation Francophone de Cancerologie Digestive: collaborator
• Grupo Espanol Tratamiento Tumores Digestivos: collaborator

Study Sites (85)

Ziekenhuis Network Antwerpen Middelheim

Antwerp, B-2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

Clinique St. Etienne

Bayonne, 64100, France

Location

Centre Hospitalier General

Belfort, 90000, France

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Clinique du Cedre

Bois-Guillaume, 76230, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier de Bourgoin - Jallieu

Bourgoin, 38300, France

Location

Centre Hospitalier General

Brivé, 19101, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier de Chalons - en - Champagne

Châlons-en-Champagne, 51000, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21034, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Clinique Pasteur

Évreux, 27000, France

Location

Cabinet de Gastro-Enterologie

Les Sables-d'Olonne, 85100, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Clinique du Pont de Chaume

Montauban, 82017, France

Location

Hopital St. Eloi

Montpellier, 34295, France

Location

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

Montpellier, 34298, France

Location

Hopital de l'Archet

Nice, F-06202, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45100, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Cochin

Paris, 75674, France

Location

Clinique Ste - Marie

Pontoise, 95301, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Hospitalier D'Agen

Saint-Esprit, 47000, France

Location

Centre Hospitalier General de Saint Nazaire

Saint-Nazaire, 44600, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

CHU Rangueil

Toulouse, 31403, France

Location

Nouvelle Clinique Generale

Valence, 26000, France

Location

CHU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Centre Hospitalier General - St. Nicolas

Verdun, 55107, France

Location

Centre Hospitalier Regionale de Vichy

Vichy, 03201, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, D-13122, Germany

Location

Saint Laurentius Ziekenhuis

Roermond, 6043 CV, Netherlands

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Hospital General

Albacete, 2006, Spain

Location

Hospital Virgen de los Lirios

Alcoi Alicante, 03800, Spain

Location

Hospital General - Alicante

Alicante, 3010, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital de Barbastro

Barbastro, 22300, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Institut d'Oncologia Corachan

Barcelona, 08017, Spain

Location

Hospital de la Santa Cruz I Sant Pau

Barcelona, 08025, Spain

Location

Hospital General Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Consorci Hospitalari de la Creu Roia

Barcelona, 08906, Spain

Location

Hospital de L'esperit Sant

Barcelona, 08923, Spain

Location

Hospital Universitario Puerta Del Mar

Cadiz, 11000, Spain

Location

Hospital Universarito "Reina Sofia"

Córdoba, 14004, Spain

Location

Hospital Virgen de Luz

Cuenca, 16002, Spain

Location

Hospital Universitario de Elche

Elche Alicante, E-03203, Spain

Location

Hospital General Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital General Universitario De Guadalajara

Guadalajara, 19002, Spain

Location

Residencia Sanitaria de Jaen

Jaén, 23007, Spain

Location

Hospital General de Jerez

Jerez de la Frontera, 11407, Spain

Location

Fundacion Jimenez Diaz - Clin. N.S.

Madrid, 28040, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Regional Carlos Haya De Malaga

Málaga, 29010, Spain

Location

Hospital De Merida

Mérida, 06800, Spain

Location

Hospital De Navarra

Pamplona, 31008, Spain

Location

Consorci Hospitalari del Parc Tauli

Sabadell, 08208, Spain

Location

Hospital de Sagunto

Sagunto, 46520, Spain

Location

Hospital Virgen de la Vega

Salamanca, 37007, Spain

Location

Hospital Universitario Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

Hospital Universitari Sant Joan d'Alacant

San Juan, 3550, Spain

Location

Hospital - Residencia Sant Camil

Sant Pere de Ribes, 08810, Spain

Location

Hospital Ntra. Sra. de la Candelaria

Santa Cruz de Tenerife, 38003, Spain

Location

Hospital Consorci Sanitari De Terrassa

Terrassa, 08227, Spain

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

Hospital General Universitario Valencia

Valencia, 46014, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, 01009, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Fensterer H, Radlwimmer B, Strater J, Buchholz M, Aust DE, Julie C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Kohne CH, Kestler HA, Schwaenen C, Nessling M, Lutz MP, Lichter P, Gress TM; EORTC Gastrointestinal (GI) Group. Matrix-comparative genomic hybridization from multicenter formalin-fixed paraffin-embedded colorectal cancer tissue blocks. BMC Cancer. 2007 Apr 2;7:58. doi: 10.1186/1471-2407-7-58.

  PMID: 17407575 BACKGROUND

• Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Fluorouracil; 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; 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

• Claus-Henning Koehne, MD

  Klinikum Oldenburg

• G. Leam

  Saint Laurentius Ziekenhuis

• Laurent Bedenne, MD

  Hopital Du Bocage

• Alfredo Carrato-Mena, MD

  Hospital Universitario de Elche

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: March 1, 1999
• Study Completion: April 1, 2007
• Last Updated: November 6, 2013

Record last verified: 2001-02

Locations

DE (1); SE (1); BE (7); FR (39); ES (36); NL (1)