Hugo Ford research projects

Abstract

Background 

Most patients with a good performance status who present with advanced oesophago-gastric cancer receive chemotherapy. Once patients relapse after first-line chemotherapy there is no data to guide further treatment. Although a number of chemotherapy agents are thought to be active in this setting there is no randomised data demonstrating the superiority of chemotherapy over supportive care. 

Relevance 

There is an important need to establish whether there is any benefit to chemotherapy in this situation,and to establish a reference regimen for newer regimens to be compared against in future studies. 

Aims 

The aim is to assess whether docetaxel chemotherapy is beneficial compared to best supportive care. If docetaxel is shown to be better than supportive care in terms of survival or health-related quality of life then this will become a reference regimen to which other chemotherapy/biological agents can be compared. 

Outline 

This is a randomised phase III study. Patients with advanced oesophago-gastric cancer who have relapsed following 1st line chemotherapy will be eligible. Patients will be randomised in a 1:1 ratio(docetaxel: active symptom control). 

The primary outcome measure of the trial is overall survival. Secondary outcomes are health-related quality of life, response rate and progression-free interval.