A study looking at endoscopic ultrasound for oesophageal cancer and gastro oesophageal junction cancer (VALUE)
Cancer type:
Status:
Phase:
This study will find out how endoscopic ultrasound helps doctors plan treatment when used with a CT scan and a PET-CT scan.
It is open to people who have:
- cancer of the food pipe (oesophagus)
- cancer of the junction between the oesophagus and the stomach (gastro oesophageal junction cancer)
More about this trial
Endoscopic ultrasound (EUS) is a procedure doctors use to find out more about your oesophageal cancer and gastro oesophageal junction cancer. This is to see whether it has spread to any nearby 
or the surrounding tissue and organs. This is called . The doctor uses the stage of your cancer to help them decide which treatments are best for you.
An EUS combines two tests, an endoscopy and an ultrasound. An endoscopy is a test to look inside your body. Your doctor uses a long flexible tube (endoscope) with a tiny camera and light on the end. The endoscope also has an ultrasound probe at its tip. An ultrasound scan uses high frequency sound waves to create a picture of the inside of your body.
There are now other ways doctors can use to stage these cancers. They can use a CT scan or a PET-CT scan. Doctors have found that using these scans to stage the cancer has changed the way they select treatment for people with these cancers. And this has raised the question of how useful EUS is to stage these cancers.
Everyone in this study has a CT scan and PET-CT scan. Your doctor will record what your treatment might be, based on the results of the scans. You then have the EUS. The study team will collect information about your care and any treatment you go on to have.
The aim of the study is to see whether using an EUS is useful and changes your treatment plan.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have had a sample of tissue (
biopsy ) taken that confirms you have oesophageal cancer or cancer of the gastro oesophageal junction. And it is an adenocarcinoma or squamous cell cancer type. - are due to have an
endoscopic ultrasound as part of your standard care - are due to have treatment with the aim to completely get rid of the cancer and to cure it. Your doctor will be able to tell you this.
- have had a
CT scan and a PET-CT scan to stage your cancer. Your doctor will know if you have. - are up and about for at least half the day, can look after yourself but might not be able to work (performance status 0, 1 or 2)
- are at least 16 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have cancer that has spread to another part of the body before you have the endoscopic ultrasound
- have cancer that has come back
- have a small amount of cancer or cancer cells that remain after treatment
- have had surgery to remove all or part of the food pipe (oesophagus)
- have had radiotherapy to the oesophagus
- are not able to have an endoscopic ultrasound
- have another type of cancer
Trial design
The team need 180 people to take part.
As part of your routine care you have:
- a CT scan and PET-CT scan
- an endoscopic ultrasound (EUS)
The study team ask your doctor to record what your treatment might be, based on the results of the CT and PET-CT scans. This treatment plan is for research purposes only. It may not be the treatment you have. This is done before you have the EUS.
After your EUS, the study team will collect further information including:
- why your doctor requested an EUS
- your treatment plan following the EUS
- whether your treatment plan changed as a result of having the EUS
- any side effects as a result of the EUS
The team might ask you to take part in an interview. They want to know about your experience in taking part in the study. The team want 30 people to interview. The interview is by video call and the team will arrange a time that is convenient for you. You don’t have to agree to the interview. You can still take part in the study.
Hospital visits
There are no extra hospital visits if you take part.
Side effects
Endoscopic ultrasound is a relatively safe procedure. Doctors have used it for many years to stage oesophageal cancer.
We have more information about having an endoscopic ultrasound and its possible side effects.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Kieran Foley
Supported by
Cancer Research UK
NIHR Research for Patient Benefit (RfPB) Programme
University of Southampton
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
