A study to improve radiotherapy for head and neck cancers (INSIGHT 2)
Cancer type:
Status:
Phase:
This study is looking at adjusting the plan of radiotherapy during treatment. This is to target the cancer better and to have less treatment to the surrounding organs.
It is open to people who are having 
for one of the following cancers:
More about this trial
Chemoradiotherapy is having chemotherapy at the same time as radiotherapy. Doctors use it to treat many head and neck cancers.
Before starting radiotherapy you have a planning appointment. This is to work out where to give the radiotherapy and how much to give. You have a CT scan. This shows the doctor where the cancer is and where to target the treatment.
You also have a mask made as part of the planning. This is to make sure your head and neck are still, and in the same spot for each treatment.
Researchers want to improve the radiotherapy planning by doing an as well as the . They also want to do another treatment plan after having the first couple of treatments. They hope that by doing this they can better target the cancer and reduce the radiotherapy to the surrounding organs. This is adaptive radiotherapy.
There are now specialised MRI scans (functional MRI scans) that better show the:
- growth of the cancer
- blood vessels going to the cancer
- difference between cancer and normal tissue
The team hope they can use these scans to target the cancer better.
There are 2 parts to this study. The feasibility study is to find out if they can use adaptive radiotherapy and the scans to improve the radiotherapy. The main study is to find out how well these work for different head and neck cancers.
The aims of the study are to find out:
- whether a treatment plan during radiotherapy using a CT scan and MRI scan can be done
- whether they can do an adaptive radiotherapy plan
- whether they can use adaptive radiotherapy to reduce the radiotherapy to the surrounding organs
- what the side effects are
- how it affects
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
There are 2 parts to the study. The feasibility study and the main study.
Who can take part
You may be able to join the feasibility study and the main study if you have one of the following cancers:
- mouth (oropharyngeal) cancer
- nasopharyngeal cancer
- nasal cancer or paranasal sinus cancer
- pharyngeal cancer
And all of the following apply. You:
- have cancer that has grown to a certain size and or has grown into the surrounding areas. Your doctor will know about this and will talk to you about it.
- are having chemoradiotherapy or chemotherapy followed by chemoradiotherapy which includes a
platinum drug such as cisplatin - are active but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are 18 to 70 years old
In the main study there are 2 groups. Each group has different entry conditions. Your doctor will know about these and will know if you are able to join any of the groups.
Who can’t take part
You cannot join the feasibility study or the main study if any of these apply. You:
- have had another cancer apart from
non melanoma skin cancer - have already had radiotherapy to the head and neck
- are not able to have an MRI scan. This could be because you have a pacemaker, you have metal anywhere in your body, you have a cochlear implant or you can’t be in small spaces.
- are not able to have an injection of the dye (
contrast medium ) used in the MRI scan. This might be because you are allergic to the dye. - have kidneys that are not working very well
Trial design
There are 2 parts in the study. The feasibility study and the main study.
Everyone has the standard chemoradiotherapy. You have radiotherapy once a day Monday to Friday for 6 weeks. Your doctor will tell you about the chemotherapy and how often you have it.
Before starting radiotherapy you have a mask fitted and made. Using the mask means your head is in the same position for each treatment.
You also have a planning appointment. This so the doctor and can work out where to give the radiotherapy and how much to give.
Feasibility study
The team need 13 people to join the feasibility study. This part is to test whether doing a CT scan and an MRI scan with the radiotherapy mask is possible.
You have a CT scan and MRI scan using the mask at:
- the planning appointment
- week 2 of treatment
- week 4 of treatment
The feasibility study is now completed. And the main study is now open to recruitment.
Main study
In the main study there are 2 groups.
Group 1
In this group the team need 25 people to join.
You have a CT scan and MRI scan using the mask at:
- the planning appointment
- week 2 of treatment
- week 4 of treatment
At week 2 and week 4 the doctor might change the radiotherapy plan depending on any changes to the cancer and the surrounding normal tissue. This is adaptive radiotherapy.
You also have a DW-MRI scan and an IVIM-MRI scan at the same time as the normal MRI scan. These are functional scans. They show:
- the blood vessels
- the growth of the cancer
- the difference cancer and normal parts of the body
Group 2
In group 2 the team need at least 10 people to join with a maximum of 53 people.
You have a CT scan and MRI scan using the mask at:
- the planning appointment
- week 2 of treatment
- week 4 of treatment
You also have a DW-MRI scan and an IVIM-MRI scan at the same time as the normal MRI scan.
At week 2 and week 4 the doctor will look at the plan of radiotherapy and change it depending on any changes they see on the scan. This is known as adaptive radiotherapy.
They will also look at the DW-MRI scan. This is to find out how well the treatment is working. If the treatment is working well enough you continue having the same dose of radiotherapy. If the it isn’t working well enough they will increase the dose of radiotherapy. You doctor will talk to you about the results of the scan at week 2 and what they mean for you.
Quality of life
Everyone in the main study fills in questionnaires before starting radiotherapy and then after finishing radiotherapy at:
- 8 weeks
- 3 months
- 6 months
- 1 year
- 1½ years
- 2 years
This is a quality of life questionnaire.
Research samples
You give blood samples during radiotherapy and a few months after finishing radiotherapy. This is apart from people in group 3 of the main study. So if you are in this group you won’t need to give any blood samples for the trial.
The study team will use these samples to look for bits of cancer in the blood (). This can tell them how well treatment is working.
Hospital visits
Everyone sees the doctor for tests before taking part. These tests include:
- a
physical examination - blood tests
- CT scan
- MRI scan
- PET-CT scan
You see the doctor each week during radiotherapy. After finishing radiotherapy you see the doctor once a week for 4 weeks and then at:
- 8 weeks
- 3 months
- 6 months
- 1 year
- 1½ years
- 2 years
You have a PET-CT scan and MRI scan at 3 months.
Side effects
The study 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.
We have information about:
• the side effects of radiotherapy to the head and neck
• chemoradiotherapy for mouth cancer
• chemoradiotherapy for nasopharyngeal cancer
Your doctor or a member of the study team will talk to you about the side effects of all the treatments before you agree to take part.
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
Dr Kee H Wong
Supported by
Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
