Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00003287
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.
- Detailed Description
OBJECTIVES: I. Compare the effects of chronomodulated versus nonchronomodulated infusional administration of a 3 drug high-dose chemotherapy regimen on survival in patients with locoregionally recurrent or metastatic colorectal cancer. II. Assess the antitumor effect of the combination of fluorouracil, leucovorin calcium, and oxaliplatin given as first line chemotherapy in these patients. III. Assess the response rate and toxicity of this treatment in these patients. IV. Assess the quality of life of patients receiving this treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (ECOG 0-1 vs 2), extent of liver involvement (none vs less than 25% vs 25% or greater), and institution. Patients are randomized into 2 arms: Arm I (chronotherapy): Patients receive a 4 day infusion of fluorouracil, leucovorin calcium, and oxaliplatin administered via pump using chronomodulated delivery rates. Arm II (fixed infusion rate): Patients receive leucovorin calcium and oxaliplatin as 2 hour concurrent infusions followed by fluorouracil as a 22 hour infusion on day 1. On day 2, patients receive a 2 hour infusion of leucovorin calcium followed by a 22 hour infusion of fluorouracil. For patients on both arms, courses repeat every 2 weeks until the occurrence of disease progression, severe toxicity, or complete remission for a minimum of 4 months. Quality of life is assessed prior to treatment and 2 weeks after courses 4 and 8. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 554 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 554
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
University Hospital of Heraklion
🇬🇷Iraklion (Heraklion), Crete, Greece
Centre Hospitalier de Montlucon
🇫🇷Montlucon, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Haukeland Hospital - University of Bergen
🇳🇴Bergen, Norway
Hospital Fernando Fonseca
🇵🇹Amadora, Portugal
Hospital De Santo Antonio Dos Capuchos
🇵🇹Lisbon (Lisboa), Portugal
Azienda Ospedaliera "Santa Maria Degli Angeli"
🇮🇹Pordenone, Italy
Sunnybrook and Women's College Health Sciences Centre
🇨🇦North York, Ontario, Canada
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Klinikum der Friedrich-Schiller Universitaet Jena
🇩🇪Jena, Germany
Azienda Ospedale S. Luigi - Universita Di Torino
🇮🇹Orbassano, (Torino), Italy
Hopital Bellevue
🇫🇷Saint Etienne, France
Krankenanstalt Rudolfstiftung
🇦🇹Vienna (Wien), Austria
Clinique Sainte Elisabeth
🇧🇪Namur, Belgium
Universita G.D'Annunzio Di Chieti
🇮🇹Chieti, Italy
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Centre Hospitalier de la Cote Basque
🇫🇷Bayonne, France
Centre Hospitalier Regional de Rimouski
🇨🇦Rimouski, Quebec, Canada
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Ospedale Oncologico Regionale
🇮🇹RIONERO in VULTURE, Italy
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Hopital Perpetuel Secours
🇫🇷Levallois-Perret, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Hopital Paul Brousse
🇫🇷Villejuif, France
Centre Hospitalier Notre Dame - Reine Fabiola
🇧🇪Charleroi, Belgium
Clinique du Parc
🇫🇷Croix, France
Hopital Cochin
🇫🇷Paris, France
Cliniques Universitaires Saint-Luc
🇧🇪Brussels (Bruxelles), Belgium
Les Cliniques Saint-Joseph ASBL
🇧🇪Liege (Luik), Belgium
Hopital Saint Jean
🇧🇪Brussels, Belgium
CHU Sart-Tilman
🇧🇪Liege, Belgium
Centre Hospitalier de Lorraine
🇧🇪Virton, Belgium
VZW Monica Campus Eewnfeestkliniek
🇧🇪Antwerpen, Belgium