High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
NCT ID: NCT00004150
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-03-31
2007-04-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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fluorouracil
leucovorin calcium
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Federation Francophone de Cancerologie Digestive
OTHER
Grupo Espanol Tratamiento Tumores Digestivos
OTHER
Robert Roessle Klinik
INDIV
Principal Investigators
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Claus-Henning Koehne, MD
Role:
Klinikum Oldenburg
G. Leam
Role:
Saint Laurentius Ziekenhuis
Laurent Bedenne, MD
Role:
Hopital Du Bocage
Alfredo Carrato-Mena, MD
Role: STUDY_CHAIR
Hospital Universitario de Elche
Locations
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Ziekenhuis Network Antwerpen Middelheim
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Hopital Universitaire Erasme
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Centre Hospitalier Peltzer-La Tourelle
Verviers, , Belgium
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
Besançon, , France
Clinique du Cedre
Bois-Guillaume, , France
CHU Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin, , France
Centre Hospitalier General
Brivé, , France
CHU de Caen
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier de Chalons - en - Champagne
Châlons-en-Champagne, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier Universitaire de Dijon
Dijon, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Clinique Pasteur
Évreux, , 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
Hopital St. Eloi
Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Hopital de l'Archet
Nice, , France
CHR D'Orleans - Hopital de la Source
Orléans, , 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 D'Agen
Saint-Esprit, , France
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, , France
Centre Paul Strauss
Strasbourg, , France
CHU Rangueil
Toulouse, , France
Nouvelle Clinique Generale
Valence, , France
CHU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Centre Hospitalier General - St. Nicolas
Verdun, , France
Centre Hospitalier Regionale de Vichy
Vichy, , France
Institut Gustave Roussy
Villejuif, , France
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Saint Laurentius Ziekenhuis
Roermond, , Netherlands
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
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
Hospital Del Mar
Barcelona, , Spain
Institut d'Oncologia Corachan
Barcelona, , Spain
Hospital de la Santa Cruz I Sant Pau
Barcelona, , Spain
Hospital General Universitari Vall d'Hebron
Barcelona, , Spain
Consorci Hospitalari de la Creu Roia
Barcelona, , Spain
Hospital de L'esperit Sant
Barcelona, , Spain
Hospital Universitario Puerta Del Mar
Cadiz, , Spain
Hospital Universarito "Reina Sofia"
Córdoba, , 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
Jaén, , Spain
Hospital General de Jerez
Jerez de la Frontera, , Spain
Fundacion Jimenez Diaz - Clin. N.S.
Madrid, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Regional Carlos Haya De Malaga
Málaga, , Spain
Hospital De Merida
Mérida, , 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 Universitario Canarias
San Cristóbal de La Laguna, , 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
Instituto Valenciano De Oncologia
Valencia, , Spain
Hospital General Universitario Valencia
Valencia, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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References
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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.
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.
Other Identifiers
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PETACC-2
Identifier Type: -
Identifier Source: secondary_id
EORTC-40963
Identifier Type: -
Identifier Source: secondary_id
FFCD-PETACC-2
Identifier Type: -
Identifier Source: secondary_id
GETTD-PETACC-2
Identifier Type: -
Identifier Source: secondary_id
CDR0000067383
Identifier Type: -
Identifier Source: org_study_id