The purpose of this study is to first determine the maximum tolerated dose of capecitabine given alone or in combination with valproic acid during preoperative short-course radiotherapy (Phase 1). The next part of the study (Phase 2)will explore whether the addition of valproic acid or the addition of capecitabine to short-course radiotherapy, before optimal radical surgery might increase the pathologic complete tumor regression rate in patients with low-moderate risk rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
25 Gy in 5 fractions over 1 week
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
RECRUITINGmaximum tolerated dose of capecitabine, given alone or in combination with valproic acid
Phase 1 primary objective
Time frame: up to 3 weeks
number of patients with complete pathological tumor regression
evaluated at definitive surgery, planned 8 weeks after the end of radiotherapy, in all the study arms of Phase 2
Time frame: 8 weeks
overall survival
Time frame: 1 year
number of patients alive with disease progression
Time frame: one year
number of patients with pathologic complete response
Time frame: 2 months
changes in quality of life from baseline
Time frame: up to 3 months
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