Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
Status:
Unknown status
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
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.