drugset / Trial / NCT01781403

Preoperative CRT With Temozolomide Plus Capecitabine in Rectal Cancer

NCT01781403 ↗

Phase 1 Completed 22 enrolled Asan Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The investigators planned a phase I study of preoperative CRT with capecitabine plus temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of temozolomide as a radiosensitizer has been well established, 2) hypermethylation (or low expression) of MGMT promoter is associated with colorectal carcinogenesis, can be found in 20\~40% of colorectal cancer patients, and this proportion could be adequate for validation as its role of predictive biomarker, and 3) temozolomide can be additive or synergistic because radiotherapy is now essential in the treatment of rectal cancer.

Timeline

Start
2013-05-10
Primary completion
2014-09-03
Completion
2016-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule — Oral

Indications