Cancer Oesophagus Gefitinib(COG)Trial - Version 1

• Research type

  Research Study

• Full title

  Cancer Oesophagus Gefitinib (COG): Phase III randomised, double-blind, placebo-controlled trial of gefitinib (Iressa®) versus placebo in oesophageal cancer progressing after chemotherapy.

• IRAS ID

  1253

• Contact name

  cog

• Sponsor organisation

  University of Oxford

• Eudract number

  2007-005391-13

• ISRCTN Number

  29580179

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  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.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  08/H0505/127

• Date of REC Opinion

  20 Oct 2008

• REC opinion

  Further Information Favourable Opinion