CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Capecitabine, Oxaliplatin +1 moredrug
Likely dose
Capecitabine, Oxaliplatin 1250 mg/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/NCT01643070
NCT01643070Phase 2Completed

Randomized Phase II Trial of Preoperative Chemoradiation With or Without Induction Chemotherapy In Patients With Locally Advanced Or Borderlinely Resectable Rectal Cancer With Resectable Synchronous Liver Metastases

Asan Medical Center·interventional·Posted Jul 17, 2012·Updated Feb 25, 2025

In Brief

A Phase 2 clinical trial evaluating Capecitabine, Oxaliplatin and Radiotherapy for Rectal Cancer and Liver Metastases. Completed, enrolled 38 participants across 1 site.

Detailed Summary

To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus capecitabine, with or without prior induction chemotherapy in patients with locally advanced or marginally resectable rectal cancer with resectable synchronous liver metastases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 14.0 years ago

Interventions

Capecitabine, Oxaliplatindrug

Induction chemotherapy - Induction XELOX (Capecitabine 1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - XELOX RT (Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.)

Radiotherapyradiation

Preoperative radiotherapy, 5040 cGy with 28 fractions