Three-Arm Randomized Trial Of Sodium Alginate, Orally Administered Mucoprotective Agent, For Preventing Radiation Esophagitis In Pts With Locally Advanced Non-Small-Cell Lung Cancer (La-Nsclc) Receiving Concurrent Chemoradiotherapy (Crt): Okayama Lung Cancer Study Group 1401.

TPS9641 Background: Concurrent CRT is the standard treatment in LA-NSCLC. Our phase 3 trial also showed a favorable efficacy of cisplatin-docetaxel and concurrent thoracic radiotherapy (JCO 2010). However, this intensive therapy can cause G3 or worse severe esophagitis of around 14%~27%, which would deteriorate pt’s QOL and then lead to poor treatment compliance. Unfortunately, various types of supportive therapy including amifostine have failed to demonstrate the prevention of this toxicity. Sodium Alginate, already approved in Japan for gastritis, is highly viscous enough to stay long on the esophageal mucosa, leading to a mucosal protective effect in esophagus. To investigate if the agent indeed has a preventive effect for severe esophagitis in pts receiving concurrent CRT, we started three-arm randomized trial of sodium alginate with two different schedules vs. water. Methods: Pts have to meet the followings: untreated LA-NSCLC; suitable for receiving CRT; PS of 0 or 1; age u003e 20 yrs. The primary endpo...