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CompletedInterventional

A phase III trial of intensity-modulated proton beam therapy versus intensity-modulated radiotherapy for multi-toxicity reduction in oropharyngeal cancer

This study, known as the TORPEDO trial, looks at treatments for cancer affecting the back of the throat, also known as oropharyngeal cancer. The standard treatment is usually chemotherapy combined with a modern type of radiotherapy called IMRT. While effective, radiotherapy can cause long-term side effects, such as a dry mouth, difficulty swallowing, and changes in speech. In this trial, doctors are comparing standard radiotherapy with proton beam therapy. Proton beams can be targeted very precisely. This may mean less radiation reaches healthy tissues nearby, potentially reducing unwanted side effects. Participants will be randomly chosen to receive either standard radiotherapy or proton beam therapy, both given alongside chemotherapy. The study will look closely at swallowing, quality of life, and how well each treatment works against the cancer.

At a glance

Status
Completed
Sponsor
Institute of Cancer Research
Enrolment target
183
Start
15 Feb 2020
Estimated completion
01 Sep 2023

What is this study about?

Oropharyngeal cancer affects the area at the back of the mouth, including the tonsils and the base of the tongue. Most people with this type of cancer receive a combination of chemotherapy and radiotherapy. Modern standard radiotherapy, called IMRT, uses high-energy X-rays to destroy cancer cells. While it is very effective, it can still damage healthy tissues nearby, causing lasting side effects such as painful swallowing, dry mouth, and changes to your voice.

Proton beam therapy is an alternative form of radiotherapy that uses tiny charged particles called protons rather than X-rays. Because of the way protons work, doctors can stop them directly inside the tumour. This means very little radiation passes into the healthy tissues behind it. Doctors hope this will reduce short-term and long-term damage to the mouth, throat, and swallowing muscles.

The main goal of this trial is to discover whether proton beam therapy reduces side effects and improves daily quality of life compared to standard radiotherapy, without lowering the chances of curing the cancer. The results could help shape future NHS treatment guidelines for people diagnosed with throat cancer across the UK.

Key takeaways

  • Compares standard radiotherapy (IMRT) with proton beam therapy for throat cancer.
  • Aims to find out if proton therapy causes fewer long-term swallowing and mouth problems.
  • Both treatment groups receive chemotherapy alongside their radiotherapy.
  • Participants are chosen at random by a computer for one of the two treatments.
  • Taking part may require temporary travel to a specialist UK proton centre.
  • Participation is entirely voluntary and does not affect your standard NHS care.

Who may be eligible?

You may be able to join this trial if you are 18 or older and have newly diagnosed squamous cell cancer of the oropharynx (throat) that requires treatment with both chemotherapy and radiotherapy to both sides of the neck. You need to be generally well enough to manage day-to-day activities, have well-working kidneys, and be willing to travel to a specialist NHS proton beam centre if selected for that treatment.

You will not be able to take part if you have already had radiotherapy to your head or neck, if you have had major surgery in the last six months, or if you already needed a feeding tube to eat because of severe swallowing issues before diagnosis. People with a heart pacemaker, other active cancers in the last two years, or significant long-term speech and swallowing problems unrelated to their cancer are also unable to join.

Women who are pregnant or breastfeeding cannot join, and both men and women who can have children must agree to use effective contraception throughout the study. Your care team will do tests to ensure your kidneys and general health meet the safety rules before you join.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with cancer of the oropharynx (back of the throat).
  3. My medical team has recommended both radiotherapy and chemotherapy.
  4. I have not had previous radiotherapy to the head or neck.
  5. I do not have a heart pacemaker or implantable heart device.
  6. I am able and willing to travel for specialist treatment if required.
Answer every question to see your result.

What does participation involve?

If you take part, a computer will randomly place you into one of two groups. One group receives standard radiotherapy (IMRT) combined with chemotherapy. The other group receives proton beam therapy (IMPT) combined with chemotherapy. Both treatments are given over several weeks, usually once a day from Monday to Friday. If you are chosen for proton therapy, you may need to travel to stay near one of the UK's specialist proton centres (such as The Christie in Manchester) for your daily sessions.

Throughout your treatment, you will have regular hospital check-ups, blood tests, and scans to monitor your health. You will also be asked to fill in questionnaires about your swallowing, speech, and general well-being. After your treatment finishes, your medical team will follow up with you at regular clinic visits for several years to track your recovery and see how your swallowing and quality of life improve over time.

Potential risks and benefits

Taking part in this study may give you access to proton beam therapy, which could cause fewer side effects than standard treatment, though this is not guaranteed. The trial also provides regular, close health monitoring by cancer specialists. However, both treatments carry common side effects, including mouth sores, sore throat, tiredness, taste changes, and skin redness. If you are selected for proton therapy, you may also have the inconvenience of travelling and staying away from home during treatment. Taking part is completely voluntary, and you are free to withdraw from the trial at any time without your standard NHS medical care or rights being affected.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Christie NHS Foundation Trust
    Unverified
    Manchester, England
  • Leeds Teaching Hospitals NHS Trust
    Unverified
    Leeds, England
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Unverified
    Newcastle-upon-Tyne, England
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Unverified
    Sheffield, England
  • University Hospitals Bristol NHS Foundation Trust
    Unverified
    Bristol, England
  • Royal United Hospitals Bath NHS Foundation Trust
    Unverified
    Bath, England
  • University College London Hospitals NHS Foundation Trust
    Unverified
    London, England
  • University Hospitals Coventry and Warwickshire NHS Trust
    Unverified
    Coventry, England
  • Portsmouth Hospitals NHS Trust
    Unverified
    Portsmouth, England
  • The Royal Marsden NHS Foundation Trust
    Unverified
    London, England
  • Worcestershire Acute Hospitals NHS Trust
    Unverified
    Worcester, England
  • University Hospital Southampton NHS Foundation Trust
    Unverified
    Southampton, England

Common questions

Can I choose to have proton beam therapy instead of standard treatment?

No. A computer will randomly assign you to receive either standard radiotherapy or proton therapy. This ensures the trial results are fair and reliable.

Will I have to pay for proton therapy or travel?

NHS clinical trials do not charge for your medical care. Trial teams usually offer support or cover travel and accommodation expenses if you need to travel to a proton centre.

Will both treatments cure my cancer equally well?

Both treatments deliver the planned cancer-fighting dose. Researchers expect proton therapy to be just as effective as standard radiotherapy, but with fewer long-term side effects.

What happens if I already have a feeding tube?

If a feeding tube was put in place just as a precaution before treatment starts, you may still join. However, if you needed one because you could no longer swallow before diagnosis, you cannot take part.

What happens if I decide to leave the trial?

You are free to leave the study at any time. Your doctors will continue to give you the standard, high-quality NHS cancer treatment best suited to your needs.

How to find out more

Deborah Gardiner

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

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