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

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

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 Open a glossary item 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:
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 Open a glossary item)
  • 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 Open a glossary item 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 Open a glossary item
study diagram
 
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 Open a glossary item)
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. 

Location

Bangor
Bodelwyddan
Bristol
Cambridge
Cheltenham
Glasgow
London
Manchester
Middlesbrough
Newcastle upon Tyne
Northwood
Nottingham
Poole
Sheffield
Southampton
Sutton
Swansea
Wirral
Wrexham

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Matthew Hatton

Supported by

Cancer Research UK
NHS Greater Glasgow and Clyde
National Radiotherapy Trials Quality Assurance (RTTQA) Group

Other information

This is Cancer Research UK trial number CRUK/14/040.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12866

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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