At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Capecitabine 50 mgfrom 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.
A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating Capecitabine and Oxaliplatin for Rectal Cancer. Completed, enrolled 60 participants across 6 sites.
Detailed Summary
The purpose of this study is to determine the pathological complete tumor response rate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesSwitzerland
CollaboratorsSanofi-Synthélabo (Schweiz) AG
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
Primary CompletionAug 2006
Study CompletionNov 2006
First PostedFeb 2016
TodayJul 2026
First PostedFeb 29, 2016
Enrollment StartMar 1, 2005
Primary CompletionAug 1, 2006
Study CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.3 years ago
Interventions
Capecitabinedrug
Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56.
Oxaliplatindrug
Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.