CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
capecitabine +4 moredrug
Likely dose
capecitabine 1000mg/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/NCT01584544
NCT01584544Phase 1Completed
CompareCT.gov

Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

Chinese Academy of Medical Sciences·interventional·Posted Apr 25, 2012·Updated Apr 20, 2015

In Brief

A Phase 1 clinical trial evaluating capecitabine and Capecitabine for Rectal Neoplasms. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Neoplasms
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 25, 2012
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.2 years ago

Interventions

capecitabinedrug

oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Capecitabinedrug

oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Capecitabinedrug

oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Capecitabinedrug

oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Capecitabinedrug

oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation