Cancer Oesophagus Gefitinib(COG)Trial - Version 1
Cancer Oesophagus Gefitinib (COG): Phase III randomised, double-blind, placebo-controlled trial of gefitinib (Iressa®) versus placebo in oesophageal cancer progressing after chemotherapy.
University of Oxford
Oesophageal cancer is the 5th most common cause of cancer death in the United Kingdom, with 7,250 deaths occurring per annum (CRUK Cancer Stats Monograph 2004). Patients progressing after chemotherapy for advanced oesophageal cancer have an average survival of around 4 months (Ferry et al 2004). In summary, second-line chemotherapeutic approaches have limited efficacy and substantial toxicity in an often poor performance status group of patients with a poor prognosis. We therefore propose conducting a national multi-centre, randomised phase III, double-blind, placebo controlled trial, with survival as the primary end point, comparing gefitinib 500mg once daily with an identical placebo (dummy tablet). The purpose of the trial is to show that gefitinib can help patients with oesophageal cancer by either stopping or slowing the progression thereby extending their survival and hopefully improve their quality of life.
South Central - Berkshire Research Ethics Committee
Date of REC Opinion
20 Oct 2008
Further Information Favourable Opinion