A trial looking at radiotherapy to prevent cancer spreading to the brain in patients with early stage small cell lung cancer (PCI01-EULINT 1)

Cancer type:

Lung cancer
Small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at radiotherapy to stop small cell lung cancer spreading to the brain (brain metastases).

Small cell lung cancer (SCLC) is usually treated with chemotherapy. But sometimes the cancer can spread to other parts of the body, including the brain. Newly diagnosed patients with limited stage SCLC are often given a course of radiotherapy to the brain. This is to help stop cancer spreading there. This is called prophylactic (pronounced prof-ill-ack-tik) cranial irradiation (PCI).

Doctors were not sure what the best dose of radiotherapy was for PCI. The aim of this trial was to compare a standard dose to a higher dose, to see which was better in preventing lung cancer spread to the brain and to see if it helped people live longer.

Summary of results

The researchers found that a higher dose of radiotherapy was no better than standard dose radiotherapy in preventing cancer spread to the brain in people with SCLC.

This was a randomised trial. It recruited 720 people

  • Half had standard dose radiotherapy to the brain
  • Half had higher dose radiotherapy to the brain

The research team looked at some of their results 2 years after radiotherapy started. They found that

  • There was no statistically significant Open a glossary item difference in the number of people who developed cancer spread to the brain in the 2 treatment groups (29% with standard dose radiotherapy and 23% with the higher dose)
  • Slightly more people were alive and cancer free (disease free survival) in the standard dose group (33%) compared to the higher dose group (29%)
  • The number of people alive, with or without signs of cancer (overall survival]), was also higher in the standard dose group (42%) compared to the other group (37%)

It is not clear why the results for patients who had lower doses of radiotherapy were slightly better than those having higher doses.

Just over half of all patients had short term side effects, but they were generally mild and well tolerated. Slightly more people in the higher dose group had side effects than those in the standard dose group, but this could have been a chance result (in other words, it wasn’t statistically significant Open a glossary item). The most common side effects were tiredness, headaches and feeling or being sick.

The research team concluded that patients with limited stage SCLC should continue to have the standard dose of radiotherapy to prevent cancer spreading to the brain.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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 Anna Greggor

Supported by

Institute Gustave-Roussy

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 74

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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