CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 228 enrolled
Drug / intervention
capecitabine [Xeloda]drug
Likely dose
capecitabine [Xeloda] 1250mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00502671
NCT00502671Phase 4Completed
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An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.

Hoffmann-La Roche·interventional·Posted Jul 18, 2007·Updated Sep 3, 2015

In Brief

A Phase 4 clinical trial evaluating capecitabine [Xeloda] for Colorectal Cancer. Completed, enrolled 228 participants across 46 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesRussia
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2007
Enrollment StartJul 1, 2007
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 19.0 years ago

Interventions

capecitabine [Xeloda]drug

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