Title: Surveillance After Resection of Oesophageal aNd Gastric cancer (SARONG) trial
Funder: Department of Health and Social Care

Abstract: There are over 15,800 new cases of gullet (oesophageal) or stomach cancer diagnosed every year in the UK, with over 12,300 deaths per year attributed to these cancers. Currently, most patients with cancer of the gullet and stomach are treated with surgery with or without additional chemo- or radio-therapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection of these cancer types. Despite these improvements, in around two-thirds of patients treated with surgery, the cancer will return within three years and they will ultimately die from this. _x000D_ _x000D_ At present there is very little evidence as to how gullet and stomach cancer patients should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. _x000D_ _x000D_ Trial Design: This randomised controlled trial will investigate if regular radiological scans can lead to earlier detection of the cancer returning, at a stage when it is treatable. This means that participants who agree to take part will be allocated by chance to either more intensive follow-up (including regular radiological scans) or the current standard of care. The trial aims to recruit at least 951 participants in the UK over a 32 month period from at least 20 NHS hospitals. Patients undergoing surgery for gullet and stomach cancer will be invited to participate in the trial at 4 to 12 weeks after their cancer treatment. _x000D_ _x000D_ (i) The intensive surveillance group will receive a review in clinic with a member of the surgical team, and a radiological scan, at 6, 12, 18, 24, 30 and 36 months after treatment. They will also receive a camera test (endoscopy) at 12 months after treatment. _x000D_ (ii) The standard care group will receive a review in clinic at 6 and 12 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year. _x000D_ _x000D_ The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with gullet and stomach cancer. _x000D_ _x000D_ Patient involvement and dissemination: Consultation with patient groups and charities, including Heartburn Cancer UK, Oesophageal and Stomach Cancer Patient Support group, Action against Heartburn UK, and GUTS charity UK, has taken place and patients will continue to be integral to the organisation and running of the study. The findings will be presented at national and international meetings, published in a high-impact scientific journal and disseminated with a broader social media strategy. All participants taking part in the study will be informed of the findings via the study website. We anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for gullet and stomach cancer.

Lay abstract: 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? _x000D_ _x000D_ 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. _x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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. _x000D_ _x000D_ 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

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS