NCT03156036

Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC

Completed Phase 2 Last updated 7 September 2023

What this trial tests

Phase 2 trial testing Capecitabine plus temozolomide VS Capecitabine in Advanced Rectal Cancer in 64 participants. Completed in 2 February 2021.

Timeline

30 November 2017

Primary endpoint
2 February 2021

2 February 2021

Quick facts

Lead sponsor	Asan Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	30 November 2017
Primary completion	2 February 2021
Estimated completion	2 February 2021
Sites	1 location across South Korea

Drugs / interventions tested

• Capecitabine plus temozolomide VS Capecitabine — full drug profile →

Conditions studied

• Advanced Rectal Cancer — all drugs for Advanced Rectal Cancer →

Sponsor

Asan Medical Center

Who can join

20 and older, any sex, with Advanced Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Temozolomide: An Updated Overview of Resistance Mechanisms, Nanotechnology Advances and Clinical Applications.
   Ortiz R, Perazzoli G, Cabeza L, Jiménez-Luna C, et al · · 2021 · cited 144× · PMID 32589560 · DOI 10.2174/1570159x18666200626204005