Spots Global Cancer Trial Database for Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
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Trial Identification
Brief Title: Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
Official Title: Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine and Cisplatin for Inoperable Locally Advanced Non-Small-Cell Lung Cancer
Study ID: NCT01203735
Interventions
Study Description
Brief Summary: This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3 months after completion of the study treatment. Toxicity will be assessed using CTCAE, based on clinical examination and laboratory tests during the study treatment and at follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Soroka University Medical Center, Beer Sheva, , Israel
Contact Details
Name: Konstantin Lavrenkov, MD, PhD
Affiliation: Soroka University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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