A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
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
1 other identifier
interventional
1,987
13 countries
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Nov 1998
Typical duration for phase_3 colorectal-cancer
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
February 2, 2001
CompletedFirst Posted
Study publicly available on registry
March 17, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedResults Posted
Study results publicly available
June 22, 2016
CompletedJune 22, 2016
May 1, 2016
5.4 years
February 2, 2001
May 16, 2016
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free Survival
Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
Approximately 3 years
Secondary Outcomes (5)
Relapse-Free Survival
Approximately 3 years
Overall Survival
Approximately 3 years
Mean Change From Baseline in Global Health Status at Week 25
Baseline (Days -7 to 1) and at Week 25
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
Up to Week 25
Number of Participants With Any Adverse Events and Serious Adverse Events
Up to Week 29
Study Arms (2)
Capecitabine
EXPERIMENTALParticipants 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).
5-Fluorouracil + Leucovorin
ACTIVE COMPARATORParticipants 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).
Interventions
Eligibility Criteria
You may qualify if:
- adult patients 18-75 years of age;
- histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.
You may not qualify if:
- previous chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (133)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Phoenix, Arizona, 85012, United States
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Fountain Valley, California, 92708, United States
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Los Angeles, California, 90089, United States
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Hartford, Connecticut, 06102-5037, United States
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Miami, Florida, 33176, United States
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Decatur, Georgia, 30033, United States
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Columbia, Missouri, 65203, United States
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St Louis, Missouri, 63141, United States
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Albany, New York, 12208, United States
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Buffalo, New York, 14263, United States
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Cleveland, Ohio, 44195, United States
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Philadelphia, Pennsylvania, 19104, United States
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Nashville, Tennessee, 37203-1632, United States
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Austin, Texas, 78705, United States
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Tyler, Texas, 75701, United States
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Seattle, Washington, 98195, United States
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Buenos Aires, 1417, Argentina
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Buenos Aires, 1425, Argentina
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Buenos Aires, C1264AAA, Argentina
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Buenos Aires, C1270AAE, Argentina
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Adelaide, 5011, Australia
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Bendigo, 3550, Australia
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Brisbane, 4006, Australia
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Fitzroy, 3065, Australia
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Kurralta Park, 5037, Australia
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Melbourne, 3128, Australia
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Melbourne, 3181, Australia
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Perth, 6000, Australia
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Port Macquarie, 2444, Australia
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St Leonards, 2065, Australia
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Sydney, 2217, Australia
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Wodonga, 3690, Australia
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Hall in Tirol, 6060, Austria
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Innsbruck, 6020, Austria
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Klagenfurt, 9026, Austria
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Linz, 4010, Austria
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Oberwart, 7400, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1030, Austria
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Vienna, 1090, Austria
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Vienna, 1100, Austria
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Vienna, 1160, Austria
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Vienna, 1220, Austria
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Brussels, 1090, Belgium
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Porto Alegre, 90020-090, Brazil
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Rio de Janeiro, 20220-410, Brazil
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São Paulo, 01406100, Brazil
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Sorocaba, 18035-300, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Berlin, 13353, Germany
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Braunschweig, 38100, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37073, Germany
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Grenzach-Wyhlen, 79639, Germany
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Halle, 06108, Germany
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Hanover, 30171, Germany
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Kassel, 34125, Germany
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Lehrte, 31275, Germany
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Magdeburg, 39130, Germany
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München, 81245, Germany
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Oldenburg, 26121, Germany
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Oldenburg, 26133, Germany
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Ravensburg, 88212, Germany
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Regensburg, 93053, Germany
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Villingen-Schwenningen, 78052, Germany
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Wuppertal, 42210, Germany
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Haifa, 34354, Israel
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Petah Tikva, 49100, Israel
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Petah Tikva, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Aviano, 33081, Italy
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Bergamo, 24128, Italy
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Bologna, 40138, Italy
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Cuneo, 12100, Italy
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Genova, 16132, Italy
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Livorno, 57100, Italy
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Mantova, 46100, Italy
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Milan, 20121, Italy
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Mirano, 30035, Italy
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Modena, 41100, Italy
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Napoli, 80131, Italy
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Pisa, 56100, Italy
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Roma, 00135, Italy
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Roma, 00168, Italy
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Roma, Italy
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Terni, 05100, Italy
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Torino, 10123, Italy
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Torino, 10126, Italy
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Vecchiazzano, 47100, Italy
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Venezia, 30122, Italy
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Vicenza, 36100, Italy
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Lisbon, 1649-035, Portugal
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Porto, 4200-072, Portugal
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Bilbao, 48013, Spain
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Córdoba, 14004, Spain
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El Palmar Murcia, 30120, Spain
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Elche, 03203, Spain
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Jaén, 23007, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28222, Spain
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Navarra, 31008, Spain
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Palma de Mallorca, 07014, Spain
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Valencia, 46010, Spain
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Basel, 4031, Switzerland
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Basel, 4070, Switzerland
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Bellinzona, 6500, Switzerland
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Bern, 3010, Switzerland
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Sankt Gallen, 9006, Switzerland
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Zurich, 8091, Switzerland
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Aberdeen, AB25 2ZN, United Kingdom
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Belfast, BT9 7AB, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Glasgow, G4 OSF, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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Luton, LU4 0DZ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE4 6BE, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Salisbury, SP2 8BJ, United Kingdom
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Southampton, SO9 4PE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2001
First Posted
March 17, 2004
Study Start
November 1, 1998
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
June 22, 2016
Results First Posted
June 22, 2016
Record last verified: 2016-05