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A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

NCT00502671 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2015-09-03

Study results available
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Summary

This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

capecitabine [Xeloda]

1250mg/m2 po bid on days 1-14 of each 3 week cycle

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Russia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00502671 on ClinicalTrials.gov