A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
NCT ID: NCT00009737
Last Updated: 2016-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1987 participants
INTERVENTIONAL
1998-11-30
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Capecitabine
Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 every 21 days.
5-Fluorouracil + Leucovorin
Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
5-Fluorouracil
425mg/m2 iv daily from day 1 to day 5 every 28 days.
Leucovorin
20mg/m2 iv daily from day 1 to day 5 every 28 days.
Interventions
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5-Fluorouracil
425mg/m2 iv daily from day 1 to day 5 every 28 days.
Leucovorin
20mg/m2 iv daily from day 1 to day 5 every 28 days.
Capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 every 21 days.
Eligibility Criteria
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Inclusion Criteria
* histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Sankt Pölten, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Brussels, , Belgium
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São 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 im Breisgau, , Germany
Göttingen, , Germany
Grenzach-Wyhlen, , Germany
Halle, , Germany
Hanover, , Germany
Kassel, , Germany
Lehrte, , Germany
Magdeburg, , Germany
München, , Germany
Oldenburg, , Germany
Oldenburg, , Germany
Ravensburg, , Germany
Regensburg, , Germany
Villingen-Schwenningen, , Germany
Wuppertal, , Germany
Haifa, , Israel
Petah Tikva, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Aviano, , Italy
Bergamo, , Italy
Bologna, , Italy
Cuneo, , Italy
Genova, , Italy
Livorno, , Italy
Mantova, , Italy
Milan, , 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
Lisbon, , Portugal
Porto, , Portugal
Bilbao, , Spain
Córdoba, , Spain
El Palmar Murcia, , Spain
Elche, , Spain
Jaén, , 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
Sankt Gallen, , Switzerland
Zurich, , 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
Countries
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Other Identifiers
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M66001
Identifier Type: -
Identifier Source: org_study_id
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