Hugo Ford research projects
Cambridge University Hospitals NHS Trust
Tel: 01223 257131
CRUK/07/013: COUGAR-02: A randomised phase III study of docetaxel vs active symptom control in patients with relapsed oesophagogastric adenocarcinomaFunding period: 01 July 2011 to 30 June 2013
Funding scheme: Phase III Clinical Trial Grants
Funding committee: Clinical Trials Awards and Advisory Committee
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.
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.
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.
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.