Open label randomised controlled trial of intensive surveillance vs. standard postoperative follow-up in patients undergoing surgical resection for oesophageal and gastric cancer.

Study ID: 55905
Short Title: Surveillance After Resection of Oesophageal aNd Gastric cancer trial
Trust Name: PHU,UHS
Recruitment Site: Queen Alexandra Hospital,Southampton General Hospital
Disease Area: Upper GI
Phase: N/A
Expected End Date: 31/10/2025
Postcode: PO6 3LY
SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

1. Patients who have undergone surgical resection for curatively intended treatment of oesophageal or gastric cancer (adenocarcinoma and squamous cell carcinoma) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy or immunotherapy (or in combination). 2. Aged 16 years or over 3. Patients willing and able to give informed consent

A patient with not be eligible for the trial if ANY of the following apply: 1. Patients with other cancers undergoing treatment or surveillance for this cancer

Every year over 15,800 people are diagnosed with gullet (oesophageal) or stomach cancer and over 12,300 deaths are reported from both cancers in the UK. Currently, most gullet or stomach cancer patients are treated with surgery with or without additional chemo- or radio-therapy. Recently, there have been improvements in survival from these cancers, due to better therapies. However, around two-thirds of patients treated with surgery, the cancer will return within three years and they will ultimately die from this. There is 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. The SARONG study will investigate if earlier detection of cancer through more intensive surveillance results in improved survival and better quality of life for patients with gullet and stomach cancer. Participants who agree to take part will be allocated by chance to either more intensive surveillance or the current standard of care. The trial aims to recruit at least 952 participants in the UK from at least 24 NHS hospitals. Patients undergoing surgery for gullet and stomach cancer will be approached prior to hospital discharge and invited to participate in the trial around 4 to 8 weeks after their cancer treatment. (i) The intensive surveillance group will receive a clinic review, and a radiological scan, at 6, 12, 18, 24, 30 and 36 months after randomisation and a camera test (endoscopy) at 12 months after randomisation. (ii) The standard care group will receive a clinic review at 6 and 12 months post-randomisation. 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.

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