A trial to find the best way of giving an increased dose of radiotherapy to treat non small cell lung cancer (ADSCaN)

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

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

This trial is for people who have locally advanced non small cell lung cancer and are having chemotherapy followed by radiotherapy.

More about this trial

Locally advanced non small cell lung cancer (NSCLC) is when the cancer has spread into the lymph nodes Open a glossary item

or nearby structures in the chest, such as the windpipe.

Doctors will remove the cancer with surgery if possible. When surgery isn’t possible you have chemotherapy followed by radiotherapy.

Standard

radiotherapy is every day, Monday to Friday for 4 weeks.

Researchers have looked at other timetables for giving radiotherapy and the highest safe dose to give. They are called:

CHART-ED
IDEAL
I-START
Isotoxic IMRT

In this trial, the team will compare these ways of giving radiotherapy with each other and standard radiotherapy.

The aim is to find the most promising way of giving increased doses of radiotherapy. And then to do a phase 3 trial Open a glossary item

using this way.

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.

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

have non small cell lung cancer that is stage 3
have had 2 cycles of chemotherapy including cisplatin or carboplatin (platinum chemotherapy) and your cancer had responded or stayed the same
have satisfactory breathing test (pulmonary function) results
are up and about for more than half the day (performance status 0, 1 or 2)
are at least 16 years old

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

are able to have surgery to remove your cancer
are able to have chemotherapy at the same time as radiotherapy (chemoradiotherapy )
have another cancer that your doctor or the trial team think could affect you taking part
have a medical condition that isn’t controlled such as diabetes, high blood pressure, infection or heart disease
have a condition such as scleroderma or systemic lupus erythematosus that affects connective tissue
have a disease that affects the tissue and space around the air sacs of the lung (interstitial lung disease) that is causing symptoms
have another medical or mental health condition that could affect you taking part
are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need 360 people to join.

Before radiotherapy everyone has to have 2 to 4 cycles of a chemotherapy combination that includes a platinum drug such as cisplatin or carboplatin.

This is a randomised trial. Everyone is put into a group by a computer. Neither you nor your doctor can choose which group you are in. There are 5 groups.

120 people will have standard radiotherapy
60 people will have CHART-ED radiotherapy
60 people will have IDEAL radiotherapy
60 people will have I-START radiotherapy
60 people will have Isotoxic IMRT

The standard radiotherapy group will be open in all hospitals. Not all 4 experimental groups may be open in your hospital.

Standard radiotherapy

You have a treatment every day Monday to Friday for 4 weeks.

CHART-ED

You have:

3 treatments every day for 12 days including weekends
2 days (a weekend) of no treatment
2 treatments each day for 3 days

You stay in hospital for your radiotherapy. You can go home for the weekend you have no treatment (Friday afternoon to Monday morning).

IDEAL

You have treatment Monday to Friday for 5 weeks. You have:

2 radiotherapy treatments one day a week
1 radiotherapy treatment on the other 4 days of the week

I-START

You have 1 treatment every day Monday to Friday for 4 weeks.

Isotoxic IMRT

You have 2 treatments every day Monday to Friday for 4 weeks. Your treatment is individually made for you using targeted (IMRT) radiotherapy.

Each treatment takes about 15 minutes. There is a 6 hour wait between the 2 treatments on each day. You might be able to stay in the hospital during the break if you don’t live close enough to return home.

Quality of life

You fill in a questionnaire before starting treatment, every week during treatment then after treatment at:

2 months
3 months
4 months
6 months
then every 3 months to 18 months
at 2 years
then every year

The questions ask about how you are, any side effects and your general health. This is a quality of life questionnaire.

Samples

The team will ask for a sample of tissue from when you were first diagnosed. They will also ask for some blood samples. They will take these when you have your routine bloods done. They will use these samples to find out more about NSCLC and how to treat it.

Hospital visits

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

a physical examination
blood tests
breathing tests
PET scan (if needed)
chest x-ray
CT scan
heart trace (ECG )

During radiotherapy you see the doctor regularly to see how you are.

After radiotherapy you see the doctor at:

2 months
3 months
4 months
6 months
then every 3 months to 18 months
at 2 years
then every year

You have regular chest x-rays and CT scans during follow up. You have the breathing tests at 2 months and 1 year. You have a heart trace at 6 months and 1 year.

Side effects

There are early side effects that can occur during radiotherapy or soon after. They usually stop within 2 months of finishing treatment. These include:

inflammation of the food pipe (oesophagitis) that causes soreness when swallowing
inflammation of the lung that causes coughing and shortness of breath
a skin reaction where you are being treated causing redness and, or, soreness
tiredness

There are late side effects that can occur months after treatment has finished and are usually permanent. These include:

scarring or narrowing of the food pipe causing soreness and difficulty swallowing. Your doctor might be able to give you some medicine to help
breathlessness caused by scarring of the lung tissue
darkening or lightening of the skin where you had treatment

We have information about the side effects of radiotherapy to the lungs.

Your doctor will talk to you about the side effects.