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

Sponsor:	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Collaborators:	European Organization for Research and Treatment of Cancer Federation Francophone de Cancerologie Digestive Grupo Espanol Tratamiento Tumores Digestivos
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004150

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Study Start Date:

March 1999

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004150

Hide Study Locations

Locations

Belgium
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium, B-4800
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Ziekenhuis Network Antwerpen Middelheim
Antwerpen, Belgium, B-2020
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Institut Jules Bordet
Brussels, Belgium, 1000
France
Cabinet de Gastro-Enterologie
Les Sables d'Olonne, France, 85100
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospitalier D'Agen
St. Esprit, France, 47000
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin-Jallieu, France, 38300
Centre Hospitalier de Chalons - en - Champagne
Chalons-en-Champagne, France, 51000
Centre Hospitalier de Meaux
Meaux, France, 77104
Centre Hospitalier General - St. Nicolas
Verdun, France, 55107
Centre Hospitalier General de Saint Nazaire
Saint Nazaire, France, 44600
Centre Hospitalier General
Belfort, France, 90000
Centre Hospitalier General
Brive, France, 19101
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
Centre Hospitalier Regionale de Vichy
Vichy, France, 03201
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21034
Hopital St. Eloi
Montpellier, France, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Francois Baclesse
Caen, France, 14076
CHR de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
CHR D'Orleans - Hopital de la Source
Orleans, France, 45100
CHU Ambroise Pare
Boulogne Billancourt, France, F-92104
CHU de Caen
Caen, France, 14033
CHU de Nancy - Hopitaux de Brabois
Vandoeuvre-les-Nancy, France, 54511
CHU Rangueil
Toulouse, France, 31403
Clinique du Cedre
Bois-Guillaume, France, 76230
Clinique du Pont de Chaume
Montauban, France, 82017
Clinique Pasteur
Evreux, France, 27000
Clinique St. Etienne
Bayonne, France, 64100
Clinique Ste - Marie
Pontoise, France, 95301
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Cochin
Paris, France, 75674
Hopital de la Croix Rousse
Lyon, France, 69317
Hopital de l'Archet
Nice, France, F-06202
Hopital Louis Pasteur
Colmar, France, 68024
Hopital Saint Joseph
Marseille, France, 13008
Centre Paul Strauss
Strasbourg, France, 67065
Institut Gustave Roussy
Villejuif, France, F-94805
Institut Jean Godinot
Reims, France, 51056
Nouvelle Clinique Generale
Valence, France, 26000
Polyclinique De Courlancy
Reims, France, F-51100
Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany, D-13122
Netherlands
Saint Laurentius Ziekenhuis
Roermond, Netherlands, 6043 CV
Serbia
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Spain
Consorci Hospitalari de la Creu Roia
Barcelona, Spain, 08906
Consorci Hospitalari del Parc Tauli
Sabadell, Spain, 08208
Fundacion Jimenez Diaz - Clin. N.S.
Madrid, Spain, 28040
Hospital - Residencia Sant Camil
Sant Pere de Ribes, Spain, 08810
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Hospital Consorci Sanitari De Terrassa
Terrassa, Spain, 08227
Hospital de Barbastro
Barbastro, Spain, 22300
Hospital de la Santa Cruz I Sant Pau
Barcelona, Spain, 08025
Hospital de L'esperit Sant
Barcelona, Spain, 08923
Hospital De Merida
Merida, Spain, 06800
Hospital De Navarra
Pamplona, Spain, 31008
Hospital de Sagunto
Sagunto, Spain, 46520
Hospital Del Mar
Barcelona, Spain, 08003
Hospital General - Alicante
Alicante, Spain, 3010
Hospital General de Jerez
Jerez, Spain, 11407
Residencia Sanitaria de Jaen
Jaen, Spain, 23007
Hospital General Universitario De Guadalajara
Guadalajara, Spain, 19002
Hospital General Universitario Valencia
Valencia, Spain, 46014
Hospital General Virgen de las Nieves
Granada, Spain, 18014
Hospital General
Albacete, Spain, 2006
Hospital Ntra. Sra. de la Candelaria
Santa Cruz de Tenerife, Spain, 38003
Hospital Regional Carlos Haya De Malaga
Malaga, Spain, 29010
Hospital Txagorritxu
Vitoria, Spain, 01009
Hospital Universarito "Reina Sofia"
Cordoba, Spain, 14004
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Universitari Sant Joan d'Alacant
San Juan, Spain, 3550
Hospital Universitario Canarias
La Laguna, Spain, 38320
Hospital Universitario de Elche
Elche Alicante, Spain, E-03203
Hospital Universitario Puerta Del Mar
Cadiz, Spain, 11000
Hospital Universitario San Carlos
Madrid, Spain, 28040
Hospital Virgen de la Vega
Salamanca, Spain, 37007
Hospital Virgen de los Lirios
Alcoi Alicante, Spain, 03800
Hospital Virgen de Luz
Cuenca, Spain, 16002
Institut d'Oncologia Corachan
Barcelona, Spain, 08017
Instituto Valenciano De Oncologia
Valencia, Spain, 46009
Hospital General Universitari Vall d'Hebron
Barcelona, Spain, 08035

Sponsors and Collaborators

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

European Organization for Research and Treatment of Cancer

Federation Francophone de Cancerologie Digestive

Grupo Espanol Tratamiento Tumores Digestivos

Investigators

Investigator:	Claus-Henning Koehne, MD	Klinikum Oldenburg
Investigator:	G. Leam	Saint Laurentius Ziekenhuis
Investigator:	Laurent Bedenne, MD	Hopital Du Bocage
Study Chair:	Alfredo Carrato-Mena, MD	Hospital Universitario de Elche

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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, 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.

Study ID Numbers:	CDR0000067383, PETACC-2, EORTC-40963, FFCD-PETACC-2, GETTD-PETACC-2
Study First Received:	December 10, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004150 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Adjuvants, Immunologic
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009