GO2, Version 1.0
Research type
Research Study
Full title
GO2 - Alternative chemotherapy for patients with advanced gastric or oesophageal cancer where standard 3-drug combinations are inappropriate
IRAS ID
125373
Contact name
Matthew Seymour
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Eudract number
2013-000009-21
ISRCTN Number
n/a
Research summary
GO2: Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer.
Gastroesophageal (GO) cancer causes 13,000 deaths each year in the UK, at an average age of 77 years. Palliative chemotherapy can improve survival and quality of life, and is offered to an increasing proportion of patients with incurable disease. Despite this population being predominantly elderly/frail, current 3-drug palliative chemotherapy regimes have been developed in trials involving patients with a median age of less than 65 and without significant comorbidity. In addition, there is evidence of widespread variation of chemotherapy regimes used in elderly/frail patients. Data from a pilot study (321GO) established the feasibility of conducting a randomised controlled trial of palliative chemotherapy for advanced GO cancer in a frail/elderly population.
GO2 aims to establish the optimum dose intensity of 2-drug palliative chemotherapy for advanced GO cancer in frail/elderly patients, to achieve the best balance of cancer control, toxicity, patient acceptability and quality of life. It will also help to establish pre-treatment characteristics that could predict better or worse outcomes with chemotherapy at different dose intensities.
Patients with advanced GO cancer considered unfit for full-dose 3-drug chemotherapy will undergo a Comprehensive Health Assessment (CHA). Patients considered likely to benefit from chemotherapy will be randomised to receive one of three dose intensities of oxaliplatin and capecitabine. Patients considered as uncertain to benefit from chemotherapy will be randomised to one of the three dose intensities or a best supportive care arm.
GO2 aims to recruit a minimum of 500 patients across 56 UK sites over a 3 year period. It will provide the first randomised clinical trial evidence to guide the use of palliative chemotherapy in elderly/frail patients with advanced GO cancer, and has the potential to have significant impact upon clinical practice.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0229
Date of REC Opinion
30 Aug 2013
REC opinion
Further Information Favourable Opinion