A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
NCT ID: NCT02581423
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
63 participants
INTERVENTIONAL
2005-08-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Capecitabine
Participants will receive capecitabine for up to approximately 6 months.
Capecitabine
Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m\^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.
Interventions
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Capecitabine
Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m\^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry
Exclusion Criteria
* Evidence of metastatic disease including tumor cells in ascites
* Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
* Active cardiovascular disease
* Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
* Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
18 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_CHAIR
Hoffmann-La Roche
Locations
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Blagoevgrad, , Bulgaria
Rousse, , Bulgaria
Shumen, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Countries
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Other Identifiers
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ML18601
Identifier Type: -
Identifier Source: org_study_id