A trial looking at when to give radiotherapy for advanced lung cancer (PRINCE)
Cancer type:
Status:
Phase:
This trial is looking at the best time to have radiotherapy to the chest for people with 
that has spread.
It is for people who:
- are having their first
systemic treatment for advanced lung cancer - are fit enough to have radiotherapy
- don’t have any symptoms that lung cancer can cause so they don’t need radiotherapy straight away
More about this trial
Advanced lung cancer is also called metastatic lung cancer. This is stage 4 lung cancer. You might have chemotherapy, immunotherapy or both to treat this. This is .
You usually only have for advanced lung cancer if you have symptoms. These symptoms might include pain or coughing up blood. You might have radiotherapy while you are having standard treatment or afterwards. Radiotherapy can help to reduce symptoms and help you feel better.
Doctors aren’t sure if giving radiotherapy routinely to people with advanced lung cancer will help them. This means giving it early, before symptoms of lung cancer have developed. So the trial team are doing this trial to find out more.
In this trial some people have the standard treatment only. And some have standard treatment with radiotherapy.
The main aims of the trial are to find out:
- how early radiotherapy affects
quality of life - if having radiotherapy before you develop symptoms is useful
- the best dose of early radiotherapy to give
- more about the side effects
- what you and healthcare professionals think about having early radiotherapy
Who can enter
The following bullet points are a summary of 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 non small cell lung cancer that measures at least 3cm across and has spread. This may be to
lymph nodes , other parts of the same lung or to the other lung, or to another part of the body (stage 4 lung cancer). - have cancer that is suitable to treat with radiotherapy to the chest
- are well enough to have at least 4
cycles of treatment to the whole body (systemic treatment) - are up and about for at least half the day but you might not be able to work (performance status 0, 1 or 2)
- are well enough to have high dose
palliative radiotherapy to treat symptoms - are willing to use reliable contraception during the trial and for a period after if there is any chance you could become pregnant
- are at least 16 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer that has spread to the thin tissue layers that cover the brain and spinal cord
- need to have radiotherapy to the chest to help with symptoms before you are put into a treatment group for this trial
- are suitable to have a specific
targeted cancer drug or immunotherapy to treat your cancer. This would be because you have certain gene changes in your lung cancer cells. This includes EGFR, ALK, ROS-1 and BRAF. Your doctor will know this. - have already had treatment for advanced non small cell lung cancer. You may be able to take part if you had only 1
cycle of treatment. - have another medical condition that means you can’t have radiotherapy. This includes interstitial lung disease and active inflammation in the connective tissues in the body. Your doctor will know this.
- have had another cancer in the past that could affect you taking part in this trial
- are having an experimental treatment as part of another clinical trial
- are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place in the UK. The team need 472 people to take part.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have 1 of the following:
- standard treatment
- standard treatment and radiotherapy
Standard treatment
You have chemotherapy, immunotherapy or both. Your doctor will talk to you about your treatment options. This depends on which treatment the doctor thinks will work best for you.
How you have treatment depends on the type you have. You may have it as a drip into a vein or you may take tablets or capsules. Your doctor can tell you more about this and how often you have it.
You have standard treatment as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Standard treatment and radiotherapy
You have standard treatment as described above.
Before starting radiotherapy, you have a planning appointment. This is so the doctor can work out where to give the radiotherapy. It is measured in units called Gray (Gy).
You have one of the following:
- 12 radiotherapy treatments over 3 weeks. This is a total of 36 Gy.
- 13 radiotherapy treatments over 3 weeks. This is a total of 39 Gy.
Your doctor will decide which schedule of radiotherapy will work best for you.
You have it every day from Monday to Friday. It takes about 15 to 20 minutes each time. You start it within 12 weeks of joining the trial.
Quality of life
The trial team might ask you to fill out some questionnaires:
- before you start treatment
- at set times during treatment
- at set times after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study. You don’t have to agree to fill in the questionnaires if you don’t want to. It won’t affect you taking part in the rest of the trial.
Interviews
The team might ask you to take part in an interview. They might also ask you to give the name of the person you get the most support from. This is only if you are happy to do this. The team would like to interview them too.
In the interview, a member of the team will ask you some questions about the trial including what you think about having radiotherapy.
The interviews take place over the telephone or online. The team will arrange the interview for a time that suits you.
The team also plan to interview some healthcare professionals. This is to find out more about the benefits and drawbacks of having radiotherapy early. And what they think about it.
The team will audio record the interviews.
You can say no to taking part in the interviews if you don’t want to do them. It won’t affect you taking part in the rest of the trial.
Diary
The team might ask you to complete a diary. You fill this in every day and record information about side effects and how you are feeling. The team can tell you more about this.
Samples for research
The team ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests. The researchers might ask for a cancer tissue sample () from a previous surgery.
They plan to use the samples to find out why radiotherapy works better for some people than others.
You can say no to having the samples taken. It won’t affect you taking part in the rest of the trial. The team will also ask your permission to store some samples for future research. You don’t have to agree to this.
Please note, the part of the trial collecting samples isn’t open yet.
Hospital visits
You see the doctor for a and have some tests before you can take part. These include:
- blood tests
- urine tests
- a CT scan
The doctor also asks you some questions about smoking.
You have treatment at the hospital. You shouldn’t need to stay overnight.
During treatment you see the doctor regularly for blood tests and check ups. When you stop treatment the trial team contact you for a final time. They may call you to see how you are getting on.
Scans
You have a routine CT scan at:
- 4 months
- 6 months
- 9 months
- 12 months
- 15 months
- 21 months
You stop having the routine scans if your cancer gets worse.
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.
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These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of radiotherapy to the chest are:
- tiredness and weakness
- difficulty swallowing
- a cough
- skin problems such as soreness, reddening or darkening of your skin, itching or dry skin. Sometimes the skin may blister and peel.
- hair loss
- chest discomfort or pain
We have more information about:
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
Professor Matthew Hatton
Supported by
The Christie NHS Foundation Trust
Southampton Clinical Trials Unit
National Institute for Health Research (NIHR)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
