CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Capecitabine [Xeloda] +1 moredrug
Likely dose
Capecitabine [Xeloda] 825 milligramsfrom 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/NCT00796718
NCT00796718Phase 2Completed
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An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer

Hoffmann-La Roche·interventional·Posted Nov 24, 2008·Updated Aug 25, 2016

In Brief

A Phase 2 clinical trial evaluating Standard radiotherapy and Capecitabine [Xeloda] for Colorectal Cancer. Completed, enrolled 62 participants across 2 sites.

Detailed Summary

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.6 years ago

Interventions

Standard radiotherapyradiation

Administered as prescribed according to normal clinical practice.

Capecitabine [Xeloda]drug

825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.