A trial looking at proton beam radiotherapy for oesophageal cancer and gastroesophageal junction cancer (PROTIEUS)
Cancer type:
Status:
Phase:
This trial is comparing 
to standard radiotherapy for food pipe cancer and cancer where the food pipe meets the stomach.
Cancer of the food pipe is called oesophageal cancer. Cancer where the food pipe meets the stomach is called gastro oesophageal junction cancer.
It is open to people whose cancer has not spread to another organ or part of the body.
Cancer Research UK supports this trial.
More about this trial
A for oesophageal cancer and gastro oesophageal junction cancer is a combination of chemotherapy and radiotherapy (). You then have surgery.
After surgery, a looks at the tissue removed during your operation. You have after surgery if they find cancer cells in this tissue.
The standard radiotherapy is intensity modulated radiotherapy (IMRT). IMRT uses high energy x-ray (photons). The beams of IMRT are shaped to closely fit the area of cancer. So that less of the healthy cells around the cancer are affected by radiotherapy.
In this trial researchers are looking at using a different type of radiotherapy called proton beam radiotherapy. Proton beam radiotherapy uses tiny particles from the centre of atoms (protons). Protons treat the cancer by giving a sudden burst of energy when they stop. So by directing the proton beams at a cancer and making them stop inside the tumour, they destroy the cancer. And so hopefully causing little damage to the nearby healthy cells.
The trial team think that using proton beam radiotherapy instead of IMRT in chemoradiotherapy, might have fewer side effects or complications after surgery.
To find this out they need to compare the 2 different types of radiotherapy. In this trial everyone will have the standard chemotherapy as part of their chemoradiotherapy. But half the people will have IMRT and the other will have proton beam radiotherapy.
You then have your planned surgery.
The aims of this trial are to find out:
- whether using proton beam in chemoradiotherapy causes fewer side effects or complications after surgery
- how well it works
- how it affects
quality of life
Who can enter
The following bullet points are a summary of 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.
Who can take part
You may be able to join this trial if all of the following apply.
- You have oesophagus cancer or gastro oesophageal junction cancer that is an
adenocarcinoma or a squamous cell carcinoma . And the cancer might have spread to the outer covering of the food pipe (stage T2 or T3) and has spread to no more than 6 nearby lymph nodes (N0, N1 or N2). - You are able to have
chemoradiotherapy before surgery with the aim to cure. - You are able to have
immunotherapy after surgery. Your doctor will know this. - Your heart and lungs are working well enough to have surgery. And this is the case within 4 weeks of going into a treatment group (
randomisation ). Your doctor will do tests for this. - You are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1).
- You are willing to use reliable contraception during treatment and for a time after if there is any chance you or your partner could become pregnant.
- You are able and willing to go to the Proton Beam Centre at either the University College London Hospital, London or the Christie Hospital, Manchester, if you go into the proton beam treatment group.
- You are at least 16 years old.
Who can’t take part
You cannot join this trial if any of these apply. You:
- have oesophageal cancer in the upper part of the food pipe or gastro oesophageal junction cancer that goes more than 3cm into the stomach. Your doctor will know this.
- have cancer that has grown into the organs next to the food pipe or has spread to another part of the body (stage T4). Or the cancer has spread to 7 or more
lymph nodes (N3). - have had previous treatment for oesophageal cancer or gastro oesophageal cancer
- have cancer that is more than 8cm in length including the lymph nodes. Your doctor can tell you this.
- have a small metal tube (oesophageal stent) in the food pipe. You can join if you have a feeding tube such as a PEG or RIG tube to have your food and drink.
- have high blood pressure that is not controlled
- have certain
heart problems . Ask your doctor about this. - have had another cancer. This is apart from successfully treated
non melanoma skin cancer , any carcinoma in situ (CIS) , chronic lymphocytic leukaemia (CLL) that is in stable remission or prostate cancer that needs no treatment or only hormone treatment , or any other cancer and there has not been a sign of it for more than 3 years. - have any other medical condition, mental health condition or other circumstances that could affect you taking part
- are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The team need 170 people to take part.
It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The 2 groups are:
- standard radiotherapy and chemotherapy followed by surgery
- proton beam radiotherapy and chemotherapy followed by surgery
You have radiotherapy each day Monday to Friday for 3 weeks with chemotherapy weekly. This is called .
After chemoradiotherapy you have the planned surgery. Your doctor will tell you about this.
After surgery you might have immunotherapy. Your doctor will discuss this with you.
Before having radiotherapy, you have a planning appointment. This is so the radiologist and the doctor can plan where to give the radiotherapy. You have this at your local hospital.
Standard radiotherapy
This is intensity modulated radiotherapy (IMRT). You have it at your local hospital.
Proton beam radiotherapy
You go to the proton beam centre where you are due to have your radiotherapy 2 or 3 weeks before starting. This is for the radiotherapy planning appointment.
You have your radiotherapy at either the proton beam centre at University London Hospital, London or at The Christie Hospital, Manchester. You stay there for the 3 weeks while having radiotherapy.
Samples for research
The team take blood samples during the trial. Where possible they will take these samples as part of your routine care. The team will tell you more about how often and when they will take these.
They will ask for a piece of the tissue sample () taken when you were first diagnosed. And for some of the tissue removed when you have surgery. You do not have a new tissue sample taken if you join the trial.
In the future, researchers might want to use these samples. The team will ask your permission to store your samples. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
All your samples are anonymous, and you cannot be identified from them. And the samples are kept in a safe and secure place.
Quality of life
You fill in questionnaires before starting chemotherapy and then twice before surgery. After surgery you fill them in at:
- 1 month
- 3 months
- 6 months
- 9 months
- 1 year
You also fill in the questionnaires if your cancer comes back after finishing all treatment.
These are quality of life questionnaires.
Sub study
If you decide not to join the main trial, the researcher will ask if you are willing to take part in a . The sub study is an observational study. The team need about 65 people to join.
If you take part, the researcher will ask you some questions about why you decided not to join the main trial. The team will also look at your medical records for 3 years to find out about your health and healthcare.
The aims of the sub study are to find out:
- more about why people choose not to take part in trials that are looking at new treatments
- whether this affects patient outcomes
Hospital visits
You see the doctor for tests before joining. These tests include:
- a
physical examination - blood tests
- a PET-CT scan
- a CT scan
- an endoscopy ultrasound (EUS) if you have gastro oesophageal junction cancer
- a heart scan (echo or
MUGA ) - a heart trace (ECG)
a breathing test (lung function test)
You see the doctor regularly during treatment. This is to see how you are.
After radiotherapy
You see the doctor about 4 to 6 weeks after finishing radiotherapy and receive the date for your surgery.
After surgery
You see the doctor after surgery at:
- 1 month
- 3 months
- 6 months
- 9 months
- 1 year
Immunotherapy
If you have immunotherapy, we aim to start this about a month after your surgery.
Scans
You have a CT scan or PET-CT scan at regular times during your treatment, follow up and if your cancer comes back.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
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Immunotherapy drugs can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
Radiotherapy can have early (short term) side effects and late (long term) side effects.
Early side effects
Early side effects start during radiotherapy or soon after finishing. These side effects usually settle down and stop between 1 and 3 months after finishing radiotherapy.
Common early side effects of radiotherapy to the chest to treat the cancer in the food pipe include:
- tiredness (fatigue)
- sore, red skin and itching at the treatment area
- loss of appetite which might cause weight loss
- producing more saliva or mucous than normal
- inflammation of the food pipe causing pain and difficulty swallowing
- indigestion or heartburn
- feeling or being sick
- bloating and tummy (abdominal) discomfort
- hair loss at the treatment area
- inflammation of the lungs causing coughing and difficulty breathing
- sore mouth or throat
You might need to go into hospital if the side effects are bad. If you have difficulty with eating and drinking during your treatment, you might have a feeding tube put in place to help. This is then removed when the side effects have settled.
Late side effects
Late side effects can happen months or years after radiotherapy and might be permanent.
Common late side effects of radiotherapy to the chest to treat the cancer in the food pipe include:
- ongoing tiredness (fatigue)
- scarring of the lung tissue causing breathlessness and a cough
We have more information about:
We have information about:
- carboplatin and paclitaxel and its side effects
- surgery for oesophageal cancer
- immunotherapy for oesophageal cancer
- coping with the side effects of treatment
Your doctor will discuss all the treatments, their possible side effects and answer any questions you may have, before you agree to join the trial.
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
Professor Maria Hawkins
Supported by
Cancer Research UK
The Taylor Family Foundation
University College London
Other information
This is Cancer Research UK trial number CRUK/22/011.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
