A trial using a scan to improve treatment for oropharyngeal cancer during chemoradiotherapy (PEARL)

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

Cancer type:

Head and neck cancers

Mouth (oral) cancer

Status:

Closed

Phase:

Phase 2

This trial is to re-plan radiotherapy treatment half way through so they can reduce the amount of radiotherapy to the nearby healthy tissue.

It is open to people who have cancer where the back of the mouth and throat meet (oropharyngeal cancer). And human papilloma virus (HPV) is the cause of the cancer.

More about this trial

One of the treatments for oropharyngeal cancer is a combination of chemotherapy and radiotherapy (chemoradiotherapy).

Researchers are looking for ways to improve treatment. One way might be to reduce the area of radiotherapy half way through the course of treatment.

You have planning for radiotherapy before you start. This is to work out where you have treatment and how much you have. During the course of treatment Open a glossary item the area of cancer reduces.

Researchers want to plan your radiotherapy again half way through treatment. So where you have treatment matches the smaller area of cancer. By doing this they hope this reduces the amount of radiotherapy to the healthy tissue. And this will decrease the side effects of radiotherapy.

The aims of this trial are to find:

how well this works
if it is possible to do
how it affects the side effects
how it affects quality of life

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.

Who can take part

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

have oropharyngeal cancer that is a squamous cell carcinoma
have cancer that has tested positive for human papilloma virus (HPV )
are having chemoradiotherapy
have satisfactory blood test results
are willing to use reliable contraception during the trial and for 6 months after if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

have cancer that has spread into the nearby areas such as the jaw and voice box (stage T4)
have cancer that has spread to other parts of the body
have cancer that has spread to 2 or more lymph nodes
have a cancer that can’t be seen on a PET CT scan
have had previous radiotherapy to your head and neck
have had another cancer in the past 5 years apart non melanoma skin cancer and carcinoma in situ of the cervix
have or had a medical condition that affects how you swallow
are a smoker or you have stopped smoking within the past 2 years
have diabetes

Trial design

This is a phase 2 trial. The team need 50 people to join.

Before starting your chemoradiotherapy you have a radiotherapy planning appointment. This is to work out where to give the radiotherapy and how much to give.

You have 33 treatments of radiotherapy over 6 weeks.

For the first 3 weeks you have it once a day Monday to Friday (15 treatments).

For the second 3 weeks you have an extra treatment of radiotherapy each week (18 treatments).

You have the extra treatment either by having your radiotherapy twice on 1 day during the week. Or by having treatment on the weekend.

You have your chemotherapy during radiotherapy either once a week or once every 3 weeks. Your doctor will talk to you about this.

PEARL-T sub study
You give blood samples and saliva (spit) samples:

before starting treatment
2 weeks after starting treatment
at the end of treatment then
after treatment at 1 month
3 months
1 year
2 years

Researchers use these samples to look for substances (biomarkers Open a glossary item ) that they hope can help predict which people might do well or not do well with standard treatment.

You don’t have to give these samples if you don’t want to. You can still take part in the PEARL trial.

Quality of life
You fill in questionnaires:

•   before starting treatment
•   a month after you finish treatment
•   then at 6 months
•   1 year
•   2 years

This is a quality of life study.

Hospital visits

You see the doctor to have tests before taking part. These tests include:

a physical examination
blood tests
test to see how well you swallow
PET CT scan

You see the doctor each week during treatment to find out how you are.

After treatment you see the doctor at:

4 weeks
3 months
6 months
1 year
2 years

This to find out how you are and to test your swallowing.

You have a PET CT scan after 2 weeks of chemoradiotherapy and then at 3 months.

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.

The early side effects of radiotherapy happen during treatment and between 1 to 3 months after. These include: