A trial comparing different types of surgery for cancer of the food pipe (ROMIO study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Oesophageal cancer

Status:

Closed

Phase:

Phase 2

This study is comparing open, combined and keyhole surgery for people with cancer of the food pipe (oesophageal cancer).

Everyone taking part completes quality of life questionnaires before surgery and afterwards.

More about this trial

Surgery is a common treatment for oesophageal cancer. It usually involves having all or part of your oesophagus removed (an oesophagectomy).

You usually have a type of surgery called open surgery. Your surgeon makes 1 cut in your chest and 1 cut in your tummy (abdomen Open a glossary item ).

But you can also have combined surgery (both keyhole and open surgery) or just keyhole surgery.

Combined surgery involves having between 4 and 8 small cuts in your abdomen and 1 cut in your chest.

Keyhole surgery involves having between 4 to 8 small cuts in your chest and between 4 and 8 small cuts in your abdomen. You have more smaller cuts so that your surgeon can use a tube with a camera to see the inside of your oesophagus. 1 cut is used for this tube. The other cuts are used for the other instruments they need to do your operation.

The 3 types of surgery aim to remove the cancer. But doctors don’t know which type is best.

In this trial, most people have 1 of the following:

open surgery
combined surgery

People having their operation at either Southampton General Hospital or Bristol Royal Infirmary hospital have 1 of the following:

open surgery
combined surgery
keyhole surgery

The main aim of this trial is to compare how well the different types of surgery work as a treatment. And find out if it changes:

the amount of time people take to recover from surgery
quality of life
how long people live after surgery (survival)

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if all of the following apply.

You have adenocarcinoma or squamous cell cancer of the oesophagus or cancer of the gastro oesophageal junction (where the food pipe joins the stomach)
Your cancer starts at least 5 cm below a muscle that allows food to pass into the oesophagus (the cricopharyngeus muscle). Your doctor will check for this
Your cancer is staged between T1N0M0 and T4aN1M0
You are well enough to have surgery (oesophagectomy) and you’re able to have a general anaesthetic
You are at least 18 years old

You cannot join this trial if any of these apply.

You have high grade dysplasia (or stage 0)
Your cancer has grown more than 4 cm into your stomach wall
Your cancer has spread to more than 6 nearby lymph nodes
Your cancer has spread to another part of your body (stage 4). You might still be able to take part if your cancer has only spread to the tissue covering the lungs (pleura), the outer covering of the heart (pericardium) or the muscle at the bottom of the rib cage (diaphragm)
Your cancer has grown into the gastro oesophageal junction from the top of your stomach (type 3 gastro oesophageal cancer) and you are going to have surgery to remove all of your stomach (a total gastrectomy)
You are going to have chemotherapy and radiotherapy together (chemoradiotherapy) as the only treatment for your cancer
You have had operations to your chest or abdomen that the surgeon thinks would affect you being able to have keyhole or combined surgery
You have had another cancer that may affect the treatment in this trial
You are taking part in another clinical trial that could affect this trial
You are pregnant

Trial design

Researchers need about 446 people from the UK to take part.

This trial is randomised. Most people taking part are put into 1 of the following groups by a computer:

open surgery
combined surgery

Romio trial diagram
People having their operation at either Southampton General Hospital or Bristol Royal Infirmary hospital are put into 1 of the following groups by a computer:

open surgery
combined surgery
keyhole surgery

Romio trial diagram (operation at Southampton or Bristol)
Neither you nor your doctor will be able to decide which group you are in. And you will not know which group you are in until about 1 week after your surgery. This is a blind trial.

All surgeries are done in the same way as it would if you weren’t in the trial. Your doctor can tell you more about what happens during each surgery. Each surgery type can take up to 8 hours.

Your surgeon will take photos during your surgery. This is to help the trial team check that they are done in a similar way.

Quality of life
As part of this trial you complete quality of life questionnaires before your surgery and after:

3 days
6 days
12 weeks

The trial team will send the questionnaires to your home with a prepaid envelope. It asks how you have been feeling and what side effects you have had.

Audio recording and interview study
The trial team might ask you to take part in a study that looks at how information is given by the doctors.

Researchers want to find out what doctors tell you about the surgery. So they may ask if they can audio record your consultations.

They might also ask you to have an interview about your experience of taking part in this trial. This interview takes about 30 minutes. You can choose whether you have this interview face to face or over the phone.

Only members of the trial team will look at the interviews and audio recordings. They will keep these recordings for 5 years

You do not have to agree to this extra study and you can choose to only agree to the audio recordings or just to have the interview.

If you don’t want to take part in this study you can still take part in the main trial.

The trial team may ask you if they can keep the recordings for longer and to use them in future studies. They will use a computer program to remove your name from the recordings. Again, you don’t have to agree to have your records kept for longer if you don’t want to.

Hospital visits

You see a doctor and have some tests before taking part. These are part of the routine care you have before an operation. You doctor will tell you what tests you need and what they involve.

After your surgery, the trial team will phone you to see how you are. They phone you regularly over the next 2 to 3 years. The calls will take about 15 minutes each time.

To help you answer the questions asked during those calls you have a diary where you keep track of any medical appointments that you have relating to your surgery.