
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing 2 types of radiotherapy for oropharyngeal cancer.
Oropharyngeal cancer is cancer of the part of the throat behind the mouth including cancer of the tonsils.
Cancer Research UK supports this trial.
Doctors can treat oropharyngeal cancer with a combination of chemotherapy and radiotherapy (). The type of radiotherapy you have is intensity modulated radiotherapy (IMRT).
Intensity modulated radiotherapy (IMRT) is a type of conformal radiotherapy. Conformal radiotherapy shapes the radiation beams to closely fit the area of cancer.
They can form shapes that fit precisely around the treatment area. The lead leaves within the machine can move while the machine moves around the patient. This then shapes the beam of radiation to the tumour as the machine rotates.
This means that the tumour receives a very high dose and normal healthy cells nearby receive a much lower dose.
Each radiotherapy beam is divided into many small beamlets that can vary the intensity of radiation. This allows different doses of radiation to be given across the tumour.
Chemoradiotherapy works well at curing oropharyngeal cancers but the IMRT can cause short and long term side effects. These side effects can affect your quality of life.
Proton beam radiotherapy works differently to IMRT. Protons treat cancer by producing a 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 they deliver less dose to the nearby healthy cells.
So researchers think it might cause fewer side effects.
Research and the use of proton beam radiotherapy in other countries show that it is safe and works well for cancer.
The main aim of this trial is to find if proton beam radiotherapy causes fewer side effects than IMRT.
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.
Who can take part
You may be able to join the trial if your cancer is or isn’t caused by the (HPV).
The cancer must be:
And all of the following apply. You:
Who can’t take part
You cannot join this trial if any of these apply. You:
There is a sub study at The Christie Hospital in Manchester. This sub study is looking at whether a certain type of called a DWI MRI scan can help predict who might have severe side effects from treatment.
You cannot join this sub study if any of the following apply. You:
This is a phase 3 trial. The trial team need 201 people to join.
Everyone has chemoradiotherapy.
The radiotherapy part is randomised. You have either:
Neither you nor your doctor can choose which group you are in.
Out of every 3 people who join, 2 people go into the proton beam group and 1 person goes into the IMRT group.
You have radiotherapy for 6½ weeks. This is once a day Monday to Friday.
You have a planning appointment before starting treatment. This is to work out where to give the radiotherapy and how much to give.
You have a shell (mask) made to fit over your head and shoulders. You can see through the mask. It takes about 30 minutes to make. You use the shell for your planning appointment and when you have treatment.
Planning the radiotherapy takes about 45 minutes.
For treatment after you lie down on the radiotherapy couch. The then attaches the shell to the couch so that it covers your head and shoulders. The shell helps you lie still so that you are in the same position and have the treatment in the correct place each time you have treatment.
People in the IMRT group have their planning and treatment at their local hospital.
People in the proton beam group have their planning and treatment at either:
The proton beam key worker will arrange accommodation that is near the hospital if you don’t live in Manchester or London. You can have someone stay with you.
Quality of life
You fill in questionnaires:
The questions ask about:
This is a quality of life questionnaire.
Research samples
You give blood samples a number of times during the trial. Researchers will use these to find out more about why some people have more side effects from radiotherapy than others. They will also be available for other researchers to use in the future.
You don’t have to agree to give these samples. You can still take part in the trial.
Sub studies at The Christies Hospital
The trial team will ask people from both groups having treatment at The Christie Hospital to take part in one or both sub studies.
The first is looking at a type of called a DWI MRI scan. As part of the sub study you might have an extra MRI scan at week 3.
The second is looking at how treatment affects cancer in the lymph nodes. This is for people who have cancer in the lymph nodes of the neck. For this sub study the team take a sample of tissue from the lymph node:
You don’t have to agree to take part in either of these sub studies.
You see the doctor to have some tests before taking part. These tests include:
You see the doctor every week during treatment to see how you are and for blood tests.
You have a planning CT scan at week 3.
At the end of treatment you see the doctor for a physical examination and blood tests. You then see the doctor at:
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.
Proton beam radiotherapy might have fewer side effects than IMRT but this isn’t known for sure. And this is one of the things researchers are trying to find out.
During your treatment side effects usually build up gradually. Most people experience some side effects. They are usually at their worst by week 5 to 6 of your treatment and continue at their peak for 2 weeks after completion of your treatment. Then over the next 4 weeks or so your treatment side effects will slowly start to get better.
Side effects of radiotherapy to this area of your body can include:
We have more information about the long term side effects of radiotherapy.
Your doctor or a member of the trial team will talk to you about the possible side effects before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Thomson
Cancer Research UK
Institute of Cancer Research (ICR)
The Taylor Family Foundation
This is Cancer Research UK trial number CRUK/18/010.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”