drugset / Trial / NCT02288195

Summary

Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could improve overall survival. The purpose of this study is to compare the effects of chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and selective use of the standard treatment to the standard treatment of chemotherapy and radiation.

Timeline

Start
2014-08-13
Primary completion
2021-03-17
Completion
2024-03

Outcome

Missed primary endpoint

paper The non-inferiority of nCT was not confirmed with a very low incidence of local recurrence in both group. PMID 41712876 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 825 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications