Study on the association of radiotherapy with capecitabine and temozolomide followed by surgery in patients with locally advanced rectal cancer

Primary objectives: The main objective of the trial is to evaluate the activity, in terms of pathologic complete response, of the addition of temozolomide to standard concurrent capecitabine-based chemoradiation, in moleculary selected patient with low-risk locally advance rectal cancer molecularly selected formicrosetellite stability, MGMT negative IHC and MGMT promoter methylation.
Primary endpoints: Pathologic complete response (pCR), defined as complete histological regression with no available tumor cells (yT0N0) in the intention-to-treat population.