Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC

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

Timeline

Start

2017-11-30

Primary completion

2021-02-02

Completion

2021-02-02

Outcome

Met primary endpoint

paper 0%, 14.3%, 18.8% and 26.7% for the entire cohort, arms A, B, C and D, respectively (P = 0.0498 between arms A and D). PMID 36376167 ↗

Publications

• Oh CR, Kim JE, Lee JS, Kim SY, Kim TW, Choi J, Kim J, Park IJ, Lim SB, Park JH, Kim JH, Choi MK, Cha Y, Baek JY, Beom SH, Hong YS. Preoperative Chemoradiotherapy With Capecitabine With or Without Temozolomide in Patients With Locally Advanced Rectal Cancer: A Prospective, Randomised Phase II Study Stratified by O6-Methylguanine DNA Methyltransferase Status: KCSG-CO17-02. Clin Oncol (R Coll Radiol). 2023 Feb;35(2):e143-e152. doi: 10.1016/j.clon.2022.10.016. Epub 2022 Nov 12.

Drugs

Indications