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Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 — CinClare  

Locally Advanced Rectal Cancer Clinical Trial

Official title:
A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer

Clinical Trial Summary

The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02605265
Study type Interventional
Source Fudan University
Contact Ji Zhu, MD
Phone +86-2164175590
Email leo.zhu@126.com
Status Recruiting
Phase Phase 3
Start date October 2015
Completion date December 2020
View Details
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