Spots Global Cancer Trial Database for A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
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Trial Identification
Brief Title: A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Official Title: An Open-Label Randomized Phase III Study Comparing Xeloda (Capecitabine) With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C Colon Cancer
Study ID: NCT00009737
Conditions
Study Description
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-fluorouracil 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Birmingham, Alabama, United States
, Phoenix, Arizona, United States
, Fountain Valley, California, United States
, Los Angeles, California, United States
, Hartford, Connecticut, United States
, Miami, Florida, United States
, Decatur, Georgia, United States
, Columbia, Missouri, United States
, St Louis, Missouri, United States
, Albany, New York, United States
, Buffalo, New York, United States
, Cleveland, Ohio, United States
, Philadelphia, Pennsylvania, United States
, Nashville, Tennessee, United States
, Austin, Texas, United States
, Tyler, Texas, United States
, Seattle, Washington, United States
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, Adelaide, , Australia
, Bendigo, , Australia
, Brisbane, , Australia
, Fitzroy, , Australia
, Kurralta Park, , Australia
, Melbourne, , Australia
, Melbourne, , Australia
, Perth, , Australia
, Port Macquarie, , Australia
, St. Leonards, , Australia
, Sydney, , Australia
, Wodonga, , Australia
, Hall in Tirol, , Austria
, Innsbruck, , Austria
, Klagenfurt, , Austria
, Linz, , Austria
, Oberwart, , Austria
, St Pölten, , Austria
, Wien, , Austria
, Wien, , Austria
, Wien, , Austria
, Wien, , Austria
, Wien, , Austria
, Bruxelles, , Belgium
, Porto Alegre, , Brazil
, Rio de Janeiro, , Brazil
, Sao Paulo, , Brazil
, Sorocaba, , Brazil
, Calgary, Alberta, Canada
, Kelowna, British Columbia, Canada
, Winnipeg, Manitoba, Canada
, Ottawa, Ontario, Canada
, Montreal, Quebec, Canada
, Saskatoon, Saskatchewan, Canada
, Berlin, , Germany
, Braunschweig, , Germany
, Freiburg, , Germany
, Grenzach-wyhlen, , Germany
, Göttingen, , Germany
, Halle, , Germany
, Hannover, , Germany
, Kassel, , Germany
, Lehrte, , Germany
, Magdeburg, , Germany
, München, , Germany
, Oldenburg, , Germany
, Oldenburg, , Germany
, Ravensburg, , Germany
, Regensburg, , Germany
, Villingen-schwenningen, , Germany
, Wuppertal, , Germany
, Haifa, , Israel
, Petach Tikva, , Israel
, Petach Tikva, , Israel
, Rehovot, , Israel
, Tel Aviv, , Israel
, Aviano, , Italy
, Bergamo, , Italy
, Bologna, , Italy
, Cuneo, , Italy
, Genova, , Italy
, Livorno, , Italy
, Mantova, , Italy
, Milano, , Italy
, Mirano, , Italy
, Modena, , Italy
, Napoli, , Italy
, Pisa, , Italy
, Roma, , Italy
, Roma, , Italy
, Roma, , Italy
, Terni, , Italy
, Torino, , Italy
, Torino, , Italy
, Vecchiazzano, , Italy
, Venezia, , Italy
, Vicenza, , Italy
, Lisboa, , Portugal
, Porto, , Portugal
, Bilbao, , Spain
, Cordoba, , Spain
, El Palmar Murcia, , Spain
, Elche, , Spain
, Jaen, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Navarra, , Spain
, Palma de Mallorca, , Spain
, Valencia, , Spain
, Basel, , Switzerland
, Basel, , Switzerland
, Bellinzona, , Switzerland
, Bern, , Switzerland
, St Gallen, , Switzerland
, Zürich, , Switzerland
, Aberdeen, , United Kingdom
, Belfast, , United Kingdom
, Cardiff, , United Kingdom
, Edinburgh, , United Kingdom
, Glasgow, , United Kingdom
, Glasgow, , United Kingdom
, Guildford, , United Kingdom
, Leicester, , United Kingdom
, Luton, , United Kingdom
, Manchester, , United Kingdom
, Newcastle Upon Tyne, , United Kingdom
, Northwood, , United Kingdom
, Plymouth, , United Kingdom
, Salisbury, , United Kingdom
, Southampton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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