Does having regular follow-up after surgery lead to early detection of the cancer returning, resulting in improved survival and better quality of life in patients who have had gullet or gastric cancer removal?

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-to-see-if-more-frequent-follow-up-is-better-for-people-with-oesophageal-cancer-and

Background and study aims
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. Despite these improvements, in around two-thirds of patients treated with surgery, the cancer will return and lead to death within 3 years.
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.
After surgery for gullet or stomach cancer, normally patients would have a post-surgical clinic visit with their hospital around 4 to 8 weeks after their operation and then another follow-up at 6 months and 12 months after the operation. In this study, the researchers want to see if it is beneficial to patients to have more frequent clinical reviews and scans after this type of cancer surgery. This study will investigate if more regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive surveillance (including regular radiological scans and a camera test [endoscopy]) or the current standard of care. 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 or stomach cancer.

Who can participate?
Patients aged 16 years or over who have been treated with surgery for gullet and stomach cancer at around 4 to 8 weeks after their surgery

What does the study involve?
If the patient agrees to join the study, she/he will be asked to sign the SARONG study consent form. A member of the study team will then ask about the patient’s medical history and medications, and collect some information from the patient’s medical records about their diagnosis and surgery and ongoing treatment. The patient will be asked to fill in some questionnaires about their health-related quality of life. The patient can decide if he/she would like to fill in the questionnaires on paper or online via a secure study website.
Patients will then be randomly allocated into either group 1 (standard of care: normal clinical visit schedule) or group 2 (intervention: extra clinical visits with scans and an endoscopy).
The standard care group will receive a review in clinic or by telephone 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.
The intensive surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months later. They will also receive an endoscopy 12 months later.

What are the possible benefits and risks of participating?
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. The researchers anticipate that the results of the study may have a significant practice-changing impact on patients undergoing follow-up after surgery for gullet and stomach cancer.
There may be no direct benefit to the patient as a result of taking part in this study, however, if the patient is allocated to group 2 and have more regular visits including scans and an endoscopy this may result in detecting any cancer returning sooner. In addition, it is hoped that the information gained from this study will help to understand how to better follow up people treated for oesophageal and stomach cancer in the future.
Participants allocated to group 2 will have additional CT scans of their chest, abdomen and pelvis, and clinical visits, which will involve additional time in the hospital as an outpatient. CT scans use ionising radiation to form images of the body and/or provide the doctor with other clinical information. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The chances of this happening to a patient as a consequence of taking part in this study are 0.5%.
Patients will also have an upper gastrointestinal endoscopy at 12 months; this procedure does carry the potential risk of injury to the oesophagus or stomach (less than 5 in 100).

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
September 2022 to April 2029

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK)

Who is the main contact?
SARONG Trial Manager
sarong@nds.ox.ac.uk

Study website

Contact information

Prof Sheraz R Markar
Principal Investigator

Surgical Intervention Trials Unit (SITU)
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7LD
United Kingdom

ORCID ID	0000-0001-8650-2017
Phone	+44 (0) 7407 894087
Email	sheraz.markar@nds.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Oxford
University/education

Research Governance, Ethics & Assurance Team
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom

Phone	+44 (0)1865 616480
Email	RGEA.Sponsor@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

05/02/2025: Study participating centre addresses updated.
14/08/2024: The study participating centres were updated to remove Velindre University NHS Trust and add Cardiff and Vale University Health Board.
27/03/2024: Study participating centres details corrected.
19/03/2024: The following study participating centres were added: Watford General Hospital, Worcestershire Acute Hospitals NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust, Yeovil Hospital, Somerset NHS Foundation Trust, Ipswich Hospital, East Suffolk and North Essex NHS Foundation Trust, Colchester Hospital.
11/10/2023: Study participating centre address updated.
20/09/2023: A link to the HRA research summary was added.
05/09/2023: University Hospitals of Derby and Burton NHS Foundation Trust, East Kent Hospitals University NHS Foundation Trust, United Lincolnshire Hospitals NHS Trust, and NHS Greater Glasgow and Clyde were added as study participating centres.
01/08/2023: The CRUK lay summary has been added to the plain English summary.
12/06/2023: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 01/05/2023 to 09/06/2023.
3. The recruitment end date was changed from 01/10/2028 to 31/10/2025.
03/04/2023: Internal review.
09/03/2023: Trial's existence confirmed by the University of Oxford.