Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 30, 2017

Primary Completion Date

February 2, 2021

Study Completion Date

February 2, 2021

Conditions
Advanced Rectal Cancer
Interventions
DRUG

Capecitabine plus temozolomide VS Capecitabine

"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.~Chemotherapy during preoperative chemoradiotherapy:~Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~dosage: Capecitabine 825 mg/m2 twice daily, Temozolomide 75 mg/m2/day"

Trial Locations (1)

05505

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT03156036 - Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC | Biotech Hunter | Biotech Hunter