Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

Status Not yet recruiting

Clinical Trial Summary

This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA) with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered using 2 Gy daily fractions given over 5 days a week.Intravenous (i.v.) chemotherapy (ChT) with gemcitabine 300 mg/m2 will be started at the first day of 3-DCRT.Total 5-6 weekly doses of i.v. ChT will be planned.VA will be administered orally in daily dose of 800 mg. Treatment with VA will be commenced at the first day and will be terminated at last day of RT.The patients will be followed till disease progression or death.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01333631
Study type	Interventional
Source	Soroka University Medical Center
Contact
Status	Not yet recruiting
Phase	Phase 2
Start date	June 2011
Completion date	July 2015

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