Trial information
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Status: Completed
Protocol number: M66001
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study comparing adjuvant chemotherapy with Xeloda, or 5-fluorouracil plus leucovorin, on disease-free and overall survival in patients who have had surgery for colon cancer
Brief summary: This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-FU 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is 1956.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Non-inferiority in disease-free survival, overall survival, and relapse-free survival. Time frame: Event driven
Key secondary outcomes: 1. AEs, laboratory parameters, QoL. Time frame: Throughout study
Inclusion criteria:
- adult patients 18-75 years of age;
- histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.
Exclusion criteria:
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
Australia
- Adelaide
- Bendigo
- Brisbane
- Fitzroy
- Melbourne
- Perth
- Port Macquarie
- St. Leonards
- Sydney
- Wodonga
Austria
- Hall In Tirol
- Innsbruck
- Klagenfurt
- Oberwart
- St Pölten
- Wien
Belgium
Brazil
- Porto Alegre
- Rio De Janeiro
- Sao Paulo
- Sorocaba
Canada
- Calgary, AB
- Kelowna, BC
- Winnipeg, MB
- Ottawa, ON
- Montreal, QC
- Saskatoon, SK
Germany
- Berlin
- Braunschweig
- Freiburg
- Göttingen
- Grenzach-Wyhlen
- Halle
- Hannover
- Kassel
- Lehrte
- Magdeburg
- München
- Oldenburg
- Ravensburg
- Regensburg
- Villingen-Schwenningen
- Wuppertal
Israel
- Haifa
- Petah Tikva
- Rehovot
- Tel Aviv
Italy
- Aviano
- Bergamo
- Bologna
- Cuneo
- Genova
- Livorno
- Mantova
- Modena
- Napoli
- Noale (Ve)
- Pisa
- Roma
- Terni
- Torino
- Vecchiazzano
- Venezia
- Vicenza
Portugal
Spain
- Bilbao
- Córdoba
- El Palmar Murcia
- Elche
- Jaen
- Madrid
- Navarra
- Palma de Mallorca
- Valencia
Switzerland
- Basel
- Bellinzona
- Bern
- St Gallen
- Zürich
United Kingdom
- Aberdeen
- Belfast
- Cardiff
- Edinburgh
- Glasgow
- Guildford
- Leicester
- Luton
- Manchester
- Newcastle upon Tyne
- Northwood
- Plymouth
- Salisbury
- Southampton
United States
- Birmingham, AL
- Phoenix, AZ
- Fountain Valley, CA
- Los Angeles, CA
- Denver, CO
- Hartford, CT
- Miami, FL
- Decatur, GA
- Columbia , MO
- St Louis, MO
- Albany, NY
- Buffalo, NY
- Cleveland, OH
- Philadelphia, PA
- Nashville, TN
- Austin, TX
- Tyler, TX
- Seattle, WA
