RecruitingInterventional

A clinical trial to investigate if proton beam therapy with chemotherapy given before surgery for patients with oesophageal cancer that has spread to the surrounding tissues, significantly reduces the severe side effects to the heart and lungs and allows immunotherapy to be started sooner after surgery when compared with standard radiotherapy and chemotherapy before surgery, and whether this delivers value to the NHS and patients

This UK trial is exploring whether an advanced type of radiation called proton beam therapy can improve treatment for people with cancer of the food pipe (oesophagus). Before having surgery, patients usually receive chemotherapy combined with standard radiotherapy. However, standard radiotherapy can sometimes cause side effects to nearby healthy organs, like the heart and lungs. In this study, half of the participants will receive standard radiotherapy alongside chemotherapy, while the other half will receive proton beam therapy alongside chemotherapy. Proton beams can be focused very precisely, which may cause less damage to surrounding healthy tissues. The research team wants to see if proton beam therapy reduces serious side effects and helps people recover quickly enough to start standard follow-up treatments, like immunotherapy, sooner after surgery. Taking part involves treatments before surgery, followed by regular check-ups for up to three years.

At a glance

Status

Recruiting

Sponsor

University College London

Enrolment target

170

Start

11 Jun 2024

Estimated completion

01 Feb 2028

Oesophageal cancer

What is this study about?

Cancer of the oesophagus—the food pipe connecting your mouth to your stomach—is usually treated with a mix of chemotherapy, radiotherapy, and surgery. While these treatments aim to cure the cancer, standard radiotherapy can sometimes affect nearby healthy organs, such as your heart and lungs. This can cause unwanted side effects and make recovery after surgery more difficult.

Proton beam therapy is a newer, highly targeted form of radiotherapy. Unlike standard X-ray radiation, proton beams can be aimed precisely at the tumour, stopping once they reach their target. Doctors hope this approach will deliver the same cancer-fighting power while protecting healthy tissue nearby.

This nationwide NHS trial is comparing proton beam therapy to standard radiotherapy before surgery. Researchers want to see whether proton therapy reduces serious complications, improves quality of life, and allows patients to start recommended treatments like immunotherapy more quickly after their operation.

Key takeaways

Compares proton beam therapy with standard radiotherapy before surgery for oesophageal cancer.
Aims to reduce damage to the heart and lungs and lower side effects.
Participants are randomly assigned to one of two treatment groups.
Proton therapy is given in London or Manchester, with free accommodation for you and a carer.
Follow-up care and health monitoring continue for up to three years.

Who may be eligible?

This study is open to people aged 16 and over who have been diagnosed with cancer of the food pipe (oesophagus) or the area where the food pipe joins the stomach. Participants must be well enough to have major surgery and receive chemotherapy and radiotherapy.

You will not be able to join if your cancer has spread to distant parts of your body, or if you have previously had treatment for invasive oesophageal cancer. People with very large tumours, severe heart problems, or an oesophageal stent (a small tube used to keep the food pipe open) are also unable to take part.

Because proton beam therapy is currently only available at two specialist NHS centres in England (in London and Manchester), participants must be willing and able to travel to one of these centres for treatment if they are selected for that group.

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.

I am 16 years of age or older.
I have been diagnosed with cancer of the food pipe (oesophagus) that has not spread to distant organs.
My medical team agrees I am fit enough for chemotherapy, radiotherapy, and surgery.
I do not have severe heart disease or an oesophageal stent.
I am able and willing to travel to London or Manchester for radiotherapy if selected.

Answer every question to see your result.

What does participation involve?

Taking part begins with a computer randomly placing you into one of two treatment groups. One group receives standard radiotherapy with chemotherapy before surgery. The other group receives proton beam therapy with chemotherapy. Pre-surgery treatments last between 5 and 11 weeks. If you receive proton therapy, you will have treatments over three weeks at either UCLH in London or The Christie in Manchester (free accommodation is provided for you and a carer). After surgery, you may receive standard treatments such as immunotherapy for up to one year. Your care team will monitor your recovery closely with hospital visits and tests for up to a year after surgery, and the trial team will check your health records for two further years.

Potential risks and benefits

Proton beam therapy is designed to spare healthy heart and lung tissue, which could lead to fewer side effects and a smoother recovery, but this cannot be guaranteed. Like all radiotherapy, both treatments can cause side effects such as tiredness, skin redness, or swallowing difficulties. If you are placed in the proton therapy group, you will need to travel and stay away from home for a few weeks, which may feel tiring or disruptive. Joining the study is completely voluntary. You can choose to leave at any time, and doing so will not affect your standard NHS care in any way.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospitals NHS Foundation Trust
City only
London, England
The Clatterbridge Cancer Centre NHS Foundation Trust
City only
Wirral, England
Guys and St Thomas' NHS Foundation Trust
City only
London, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
City only
Norwich, England
Royal Free London NHS Foundation Trust
City only
London, England
Swansea Bay University Local Health Board
Unverified
Neath, Wales
Leeds Teaching Hospitals NHS Trust
Unverified
Leeds, England
The Christie NHS Foundation Trust
Unverified
Manchester, England
Hull University Teaching Hospitals NHS Trust
Unverified
Hull, England
Royal Devon University Healthcare NHS Foundation Trust
Unverified
Exeter, England
Cambridge University Hospitals NHS Foundation Trust
Unverified
Cambridge, England
Oxford University Hospitals NHS Foundation Trust
Unverified
Oxford, England

Common questions

What is the main difference between standard radiotherapy and proton beam therapy?

Standard radiotherapy uses X-ray beams that travel through the tumour and into tissue behind it. Proton beam therapy uses tiny particles that stop right at the tumour, aiming to protect healthy heart and lung tissue.

Can I choose which treatment group I join?

No. A computer programme randomly assigns you to either standard radiotherapy or proton beam therapy. This ensures the study gives fair, unbiased scientific results.

Where does the proton beam therapy take place?

In England, proton beam therapy is only available at University College London Hospital (UCLH) or The Christie in Manchester. Free accommodation is provided for you and a carer during treatment.

Will taking part delay my cancer surgery?

No. Both treatment plans are scheduled carefully so that you have your planned surgery at the right time.

What happens if I decide to leave the trial?

You are free to withdraw from the trial at any point. Your NHS medical team will continue to provide you with the best standard care available.

How to find out more

Natasha Hava

ctc.protieus@ucl.ac.uk +44 207 679 9608 Official trial record

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