Not yet recruitingPHASE3INTERVENTIONAL

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial

The SARONG-II study is exploring the best way to follow up patients after surgery for oesophageal (food pipe) or stomach cancer. These cancers are becoming more common, and even with better treatments, they can sometimes come back. Currently, there's no clear best way to check if the cancer has returned. This study aims to find out if having regular scans can help doctors spot cancer returning earlier, when it might be easier to treat. Patients will be randomly put into two groups: one with more intensive scans and tests, and another with standard check-ups. The goal is to see if more regular scans lead to better survival and quality of life for patients.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University of Dublin, Trinity College

Enrolment target

952

Start

01 Nov 2023

Estimated completion

01 Nov 2029

Esophageal Cancer Gastric Cancer

What is this study about?

If you've had surgery for cancer of the food pipe (oesophagus) or stomach, you might be wondering what happens next. These cancers are becoming more common, and even with all the improvements in treatment, about half of patients will unfortunately see their cancer return, usually within the first three years after surgery. At the moment, there isn't a single, clear recommendation for how often or in what way doctors should check to see if the cancer has come back. National and international guidelines often differ, meaning people might be followed up in different ways depending on where they live.

The SARONG-II study wants to find out if checking for cancer more regularly using scans can make a difference. The idea is that if cancer is spotted earlier, it might be possible to treat it more effectively. To do this, some people taking part in the study will have more frequent scans and a camera test (endoscopy), while others will have their usual check-ups. By comparing these two groups, the researchers hope to learn which approach is best for patients.

Ultimately, the main goal of this study is to see if more regular check-ups with scans can help people live longer and have a better quality of life. The results could change how all patients are followed up after oesophageal or stomach cancer surgery in the future, helping to ensure everyone receives the best possible care.

Key takeaways

This study compares two ways of checking for cancer returning after oesophagus or stomach surgery.
One group will have more regular scans and tests, the other will have standard check-ups.
The goal is to see if earlier detection leads to better survival and quality of life.
The study could change future recommendations for follow-up care.
Participation involves being randomly assigned to a group for 3 years of follow-up.

Who may be eligible?

To join this study, you must be at least 18 years old and have recently had surgery to remove oesophageal or stomach cancer. This includes cases where you might have also had chemotherapy, radiotherapy, or immunotherapy before or after your operation.

It's important that you are willing and able to give your informed consent, which means you understand what the study involves and agree to take part voluntarily.

You won't be able to join if you are currently being treated for, or being monitored for, any other type of cancer at the same time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I recently had surgery for oesophagus or stomach cancer?
Am I 18 years old or older?
Am I willing to understand and agree to take part?
Am I NOT currently being treated or monitored for another cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the study, you'll be invited to join about 4 to 8 weeks after your surgery. You'll then be randomly placed into one of two groups, like flipping a coin. This means neither you nor your doctor can choose which group you're in.

If you're in the 'imaging surveillance' group, you'll have regular check-ups either in person or over the phone with your surgical team. You'll also have scans at 6, 12, 18, 24, 30, and 36 months after you join the study. Additionally, you'll have a camera test (endoscopy) at 12 months.

If you're in the 'clinical surveillance' group, you'll have check-ups either in person or over the phone with your surgical team at 6, 12, 18, 24, 30, and 36 months. After three years, you'll either go back to your local doctor for follow-up or continue to have yearly check-ups with the surgical team, depending on what's standard practice where you live. This study will last for 3 years for each participant.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as the chance that earlier detection of cancer returning could lead to better treatment options. However, there are also potential risks, including the stress that regular scans might cause, or the very small risks associated with scans themselves. Your health and wellbeing are very important, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

University Hospital Cologne
Verified postcode
Cologne, Germany
Mercy University Hospital
Verified postcode
Cork, Ireland
Trinity St. James's Cancer Institute
Verified postcode
Dublin, Ireland
Galway University Hospital
Verified postcode
Galway, Ireland
Fondazione Policlinico Universitario Agostino Gemelli
Verified postcode
Roma, Italy
Oslo University Hospital
Verified postcode
Oslo, Norway
University Hospital of Northern Norway
Verified postcode
Tromsø, Norway
St. Olav University Hospital
Verified postcode
Trondheim, Norway
Linköping University Hospital
Verified postcode
Linköping, Sweden
Skåne University Hospital
Verified postcode
Lund, Sweden
Örebro University Hospital
Verified postcode
Örebro, Sweden
Karolinska Institutet
Verified postcode
Stockholm, Sweden

Common questions

What is oesophageal and gastric cancer?

Oesophageal cancer affects the food pipe that carries food to your stomach, and gastric cancer affects your stomach. Both are types of cancer that start in the digestive system.

Why is this study important?

This study is important because there's currently no clear best way to check for cancer returning after surgery. It aims to find out if more regular scans can help patients live longer and improve their quality of life.

What are 'radiological scans'?

Radiological scans are medical imaging tests, like CT scans, which create detailed pictures of the inside of your body to help doctors look for any changes.

What does 'randomly allocated' mean?

It means you'll be put into one of the study groups by chance, like flipping a coin. This ensures the study is fair and unbiased, so we can accurately compare the different follow-up methods.

Will my care be affected if I don't join the study?

No, your decision to join or not join the study will not affect the standard medical care you receive for your cancer.

How to find out more

Jessie A Elliott, PhD FRCS

sarong@tcd.ie +353 1 410 3900 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.