Surveillance After Resection of Oesophageal aNd Gastric cancer (SARONG): A Registry-based Randomised Controlled Trial

Purpose: The majority (60%) of oesophageal and gastric cancer treated curatively will die from recurrence within 3-years, yet there are no guidelines for surveillance after treatment.Aims: To determine the impact of intensive surveillance on survival and health-related quality of life (HRQOL) after surgery for oesophago-gastric cancer.Methods: Study design – Registry-based RCT, using existing Scandinavian cancer registries.Organisation – When patients meet their surgeon at the out-patient clinics first time after surgery (approximately 6 weeks after), they will be randomised to either:(a) Intervention group; with intensive follow-up for up to 3-years after surgery, including clinical and radiological investigation every 6 months.(b) Control group; Standard follow-up, which will comprise only clinical review at 6 and 12 months.Key clinical and survival data will be retrieved from all hospitals involved from data entered into existing Nordic, Dutch and UK registries.

The primary outcome will be 3-year all-cause mortality and the secondary outcomes will include HRQOL, 3-year disease specific mortality, pattern and treatment of recurrence.Time plan – 1-year for project step, 18 months of patient recruitment, 3-years follow-up with 6 months data analysis.Importance: 1) Provide evidence-based surveillance regimes after oesophago-gastric cancer surgery for prognostic and HRQOL benefit. 2) Demonstrate the utilisation of a registry-based RCT design in an oncological setting.