A trial looking at higher dose radiotherapy for non small cell lung cancer (I-START)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 1/2

This trial looked at giving a higher than normal dose of radiotherapy for non small cell lung cancer (NSCLC). It was for people who couldn’t have, or didn’t want to have, surgery.

The trial was supported by Cancer Research UK. It was open for people to join between 2012 and 2014. The team presented some results about side effects at a conference in 2018.

More about this trial

Doctors sometimes treat non small cell lung cancer (NSCLC) with radiotherapy.

Researchers thought that giving a higher dose of radiotherapy may work better. But they wanted to check this didn’t damage the surrounding healthy tissue such as the food pipe (oesophagus). This can cause side effects.

Everyone taking part had radiotherapy. But people had different doses, so the team could find the best dose to use.

The main aims of this trial were to find out:

  • the best dose of radiotherapy to use
  • more about the side effects of different doses of radiotherapy
  • how well higher dose radiotherapy works
  • whether it’s worth doing more trials to look at higher dose radiotherapy for NSCLC

Summary of results

A total of 80 people joined this trial. They were all due to have radiotherapy to treat their non small cell lung cancer (NSCLC)

Radiotherapy is measured in Gray (Gy). The total dose of radiotherapy is split into smaller doses called fractions. People in this trial had 20 fractions of radiotherapy over 4 weeks. 

When this trial was done, doctors usually treated non small cell lung cancer with between 50 and 55Gy.

People in this trial had between 52Gy and 65Gy to the area of cancer. The dose they had to their oesophagus was either the same or slightly less than this. The exact dose depended how close their oesophagus was to the area of cancer being treated.

The research team analysed the results by grouping people according to how much radiotherapy they had to their oesophagus:

  • Group Y = 48 people had a total dose of 55Gy or more 
  • Group Z = 32 people had a total dose of less than 55Gy 

Side effects
The team looked at the number of people who had moderate or severe side effects. They found it was:

  • 6 people (13%) in group Y who had the higher doses
  • 2 people (6%) in group Z who had the lower doses

The most common side effects were:

  • extreme tiredness (fatigue)
  • cough
  • shortness of breath (dyspnoea) 

Radiotherapy can cause inflammation of the oesophagus (oesophagitis). One person who had higher dose radiotherapy had moderate oesophagitis. 

It can also cause inflammation of the lung (pneumonitis). Three people had moderate or severe pneumonitis. 

Conclusion
The team concluded that higher dose radiotherapy for non small cell lung cancer didn’t cause too many side effects. They suggest this is looked at in other trials.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Initial results of the phase ib/II, I-START trial: Isotoxic accelerated radiotherapy for the treatment of stage II-IIIb NSCLC.
J F Lester and others
Journal of Clinical Oncology, 2018. Volume 36, number 15 (supplement).

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and presented at a medical conference. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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

Dr Jason Lester

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Velindre NHS Trust
Wales Cancer Trials Unit

Other information

This is Cancer Research UK trial number CRUK/10/005.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 5092

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

Last reviewed:

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