Spots Global Cancer Trial Database for High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
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
Study ID: NCT00004150
Conditions
Study Description
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.
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ziekenhuis Network Antwerpen Middelheim, Antwerpen, , 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, Liege, , 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, 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
CHU de Caen, Caen, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Hospitalier de Chalons - en - Champagne, Chalons-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, 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
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, 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, , 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", 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
Instituto Valenciano De Oncologia, Valencia, , Spain
Hospital General Universitario Valencia, Valencia, , Spain
Hospital Txagorritxu, Vitoria, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: Claus-Henning Koehne, MD
Affiliation: Klinikum Oldenburg
Role:
Name: G. Leam
Affiliation: Saint Laurentius Ziekenhuis
Role:
Name: Laurent Bedenne, MD
Affiliation: Hopital Du Bocage
Role:
Name: Alfredo Carrato-Mena, MD
Affiliation: Hospital Universitario de Elche
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
