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Advanced Rectal Cancer clinical trials

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NCT ID: NCT03156036 Completed - Clinical trials for Advanced Rectal Cancer

Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer. The primary endpoint is pathologic complete response rates defined as total regression of the primary tumor. For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms. According to the prior phase I results, MGMT hypermethylated arm is estimated as 70% of total patients and the target pathologic complete response rate was assumed as 35% in this population when treated with preoperative CRT with temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete responses when treated with preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer, and to validate the predictive role of MGMT status