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

Colorectal Cancer Clinical Trial

Official title:

Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004150
• Other study ID #: CDR0000067383
• Secondary ID: PETACC-2EORTC-40
• Status: Completed
• Phase: Phase 3
• First received: December 10, 1999
• Last updated: November 5, 2013
• Start date: March 1999
• Est. completion date: April 2007

Study information

• Verified date: February 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection.

• Compare the safety of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.

Patients are randomized to one of two treatment arms.

• Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.

• Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.

OR

• Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses.

OR

• Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses.

Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• fluorouracil

• leucovorin calcium

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Belgium	Ziekenhuis Network Antwerpen Middelheim	Antwerpen
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	CHU Liege - Domaine Universitaire du Sart Tilman	Liege
Belgium	Centre Hospitalier Peltzer-La Tourelle	Verviers
France	Centre Hospitalier Regional et Universitaire d'Angers	Angers
France	Clinique St. Etienne	Bayonne
France	Centre Hospitalier General	Belfort
France	CHR de Besancon - Hopital Jean Minjoz	Besancon
France	Clinique du Cedre	Bois-Guillaume
France	CHU Ambroise Pare	Boulogne Billancourt
France	Centre Hospitalier de Bourgoin - Jallieu	Bourgoin-Jallieu
France	Centre Hospitalier General	Brive
France	Centre Regional Francois Baclesse	Caen
France	CHU de Caen	Caen
France	Centre Hospitalier de Chalons - en - Champagne	Chalons-en-Champagne
France	Hopital Louis Pasteur	Colmar
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Clinique Pasteur	Evreux
France	Cabinet de Gastro-Enterologie	Les Sables d'Olonne
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Hopital de la Croix Rousse	Lyon
France	Hopital Saint Joseph	Marseille
France	Centre Hospitalier de Meaux	Meaux
France	Clinique du Pont de Chaume	Montauban
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Hopital St. Eloi	Montpellier
France	Hopital de l'Archet	Nice
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Cochin	Paris
France	Clinique Ste - Marie	Pontoise
France	Institut Jean Godinot	Reims
France	Polyclinique De Courlancy	Reims
France	Centre Hospitalier General de Saint Nazaire	Saint Nazaire
France	Centre Hospitalier D'Agen	St. Esprit
France	Centre Paul Strauss	Strasbourg
France	CHU Rangueil	Toulouse
France	Nouvelle Clinique Generale	Valence
France	CHU de Nancy - Hopitaux de Brabois	Vandoeuvre-les-Nancy
France	Centre Hospitalier General - St. Nicolas	Verdun
France	Centre Hospitalier Regionale de Vichy	Vichy
France	Institut Gustave Roussy	Villejuif
Germany	Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch	Berlin
Netherlands	Saint Laurentius Ziekenhuis	Roermond
Serbia	Institute of Oncology and Radiology of Serbia	Belgrade
Spain	Hospital General	Albacete
Spain	Hospital Virgen de los Lirios	Alcoi Alicante
Spain	Hospital General - Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital de Barbastro	Barbastro
Spain	Consorci Hospitalari de la Creu Roia	Barcelona
Spain	Hospital de L'esperit Sant	Barcelona
Spain	Hospital de la Santa Cruz I Sant Pau	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital General Universitari Vall d'Hebron	Barcelona
Spain	Institut d'Oncologia Corachan	Barcelona
Spain	Hospital Universitario Puerta Del Mar	Cadiz
Spain	Hospital Universarito "Reina Sofia"	Cordoba
Spain	Hospital Virgen de Luz	Cuenca
Spain	Hospital Universitario de Elche	Elche Alicante
Spain	Hospital General Virgen de las Nieves	Granada
Spain	Hospital General Universitario De Guadalajara	Guadalajara
Spain	Residencia Sanitaria de Jaen	Jaen
Spain	Hospital General de Jerez	Jerez
Spain	Hospital Universitario Canarias	La Laguna
Spain	Fundacion Jimenez Diaz - Clin. N.S.	Madrid
Spain	Hospital Universitario San Carlos	Madrid
Spain	Hospital Regional Carlos Haya De Malaga	Malaga
Spain	Hospital De Merida	Merida
Spain	Hospital De Navarra	Pamplona
Spain	Consorci Hospitalari del Parc Tauli	Sabadell
Spain	Hospital de Sagunto	Sagunto
Spain	Hospital Virgen de la Vega	Salamanca
Spain	Hospital Universitari Sant Joan d'Alacant	San Juan
Spain	Hospital - Residencia Sant Camil	Sant Pere de Ribes
Spain	Hospital Ntra. Sra. de la Candelaria	Santa Cruz de Tenerife
Spain	Hospital Consorci Sanitari De Terrassa	Terrassa
Spain	Hospital General Universitario Valencia	Valencia
Spain	Instituto Valenciano De Oncologia	Valencia
Spain	Hospital Txagorritxu	Vitoria
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza

Sponsors (4)

Lead Sponsor	Collaborator
Robert Roessle Klinik	European Organisation for Research and Treatment of Cancer - EORTC, Federation Francophone de Cancerologie Digestive, Grupo Espanol Tratamiento Tumores Digestivos

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Serbia,  Spain, 

References & Publications (2)

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.

Fensterer H, Radlwimmer B, Sträter J, Buchholz M, Aust DE, Julié C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Köhne 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. — View Citation