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Brief Title: Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer
Official Title: Phase 1/2 Study of Valproic Acid and Short-course Radiotherapy Plus Capecitabine as preoperatIve Treatment in Low-moderate Risk Rectal Cancer
Study ID: NCT01898104
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
Name: Antonio Avallone, M.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR