Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
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