Spots Global Cancer Trial Database for Valproic Acid With Chemoradiotherapy for Pancreatic Cancer
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Trial Identification
Brief Title: Valproic Acid With Chemoradiotherapy for Pancreatic Cancer
Official Title: Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Gemcitabine for Unresectable Locally Advanced Pancreatic Cancer
Study ID: NCT01333631
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Konstantin Lavrenkov, MD, PhD
Affiliation: Soroka University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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