Surveillance After Resection of Oesophageal aNd Gastric cancer (SARONG) trial

RESEARCH QUESTION: Does the routine use of a structured follow-up program with regular radiological and endoscopic investigations improve survival in patients who have had surgical treatment for oesophageal or gastric cancer with curative intent? BACKGROUND: Despite recent improvements in oncological and surgical treatment for patients with oesophageal and gastric cancer, 60% of patients with locally advanced disease who are treated curatively will develop tumour recurrence and die within three years of treatment. In the absence of robust scientific evidence international guidelines have failed to reach consensus on the optimal surveillance strategy after primary treatment of oesophageal or gastric cancer. AIMS/OBJECTIVES: To assess whether structured follow-up, including radiological and endoscopic investigations after completing curatively intended treatment, improves survival in patients with oesophageal or gastric cancer. Secondary aims are to determine the impact of surveillance upon the detection and treatment of cancer recurrence and health-related quality of life, and to assess the cost-effectiveness of routine clinical, radiological and endoscopic investigations compared with the current practice, led by clinical symptomatic follow-up. METHODS: A prospective, multi-centre, randomised controlled trial of structured follow-up including radiological and endoscopic investigations versus standard clinical follow-up. The setting will be at least 20 large oesophago-gastric cancer UK cancer centres. We will aim to recruit 951 oesophageal and gastric cancer patients receiving surgical resection for curatively intended treatment of oesophageal or gastric cancer +/- neoadjuvant/adjuvant chemo(radio)therapy. At 4-12 weeks after the completion of oncological therapy, patients will be assessed for eligibility for inclusion in the trial. Patients will be randomised 1:1 to receive either intensive follow-up for up to 3-years, with clinical and computerised tomography (CT) or PET-CT investigation every 6 months, and an endoscopy at 12 months, or to current standard NHS follow-up, i.e. clinical review at 6 and 12 months followed by targeted investigation as required based on the onset of new symptoms. The primary outcome is 3-year all-cause mortality and secondary outcomes include health-related quality of life (including anxiety), 3-year disease-specific mortality, pattern and treatment of tumour recurrence, and cost-effectiveness of follow-up in both study arms. Patients will be followed-up either in clinic or via telephone at baseline, 6, 12, 18, 24, 30 and 36 months post-randomisation. TIMELINES FOR DELIVERY: The total length of the trial is 80 months. Recruitment will last 32 months and there will be a formal stop/go review of the internal pilot in month 15 of the project (9th month of recruitment) to ensure that a minimum of 9 centres are active and are recruiting at least 2 patients/centre/month. Data from the patients in the internal pilot phase will be included in the final analysis. ANTICIPATED IMPACT AND DISSEMINATION: We anticipate that the study results will change national guidelines for oesophageal and gastric cancer patients and thus affect over 4000 patients who are treated with surgery in the UK annually. The findings are likely to extend beyond the UK and dissemination will be through publications, presentations and appropriate use of media. We have incorporated a full patient and public involvement programme