A randomized phase III study in advanced esophageal cancer (OC) to compare the quality of life (QoL) and palliation of dysphagia in patients treated with radiotherapy (RT) or chemoradiotherapy (CRT) TROG 03.01 NCIC CTG ES.2.

4009 Background: RT is known to relieve dysphagia of advanced oesophageal cancer, there is no data from randomised phase III trials determining response, toxicity, or role of palliative CRT. Aims 1) to establish effective and least toxic treatment for symptom relief of advanced OC 2) determine effects of common cancer treatments on QoL and end of life care 3) establish an evidence base for patient decision making regarding the optimal management for incurable OC. Methods: 220 patients were randomised to receive a course of palliative RT [35 Gy in 15 fractions, (n=115) or 30 Gy in 10 fractions (n=105) in Canada and UK], or concomitant CRT with Cisplatin and 5FU (D1-4) (n=111). Dysphagia was measured using the Mellow score, toxicity using CTCAE v2, and QoL using EORTC QLQ30 and oesophagus module (OES-18). The primary end point was the proportion of patients with improved dysphagia as measured at week 9 and maintained until week 13. Results: The patients receiving radiotherapy alone showed a dysphagia respon...