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A study looking at adding an increased dose of radiation to CHART radiotherapy to treat non small cell lung cancer (CHART ED)

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

This study is to see if it is possible to improve the outcome of radiotherapy for non small cell lung cancer, by adding extra radiotherapy sessions to an intensive radiotherapy treatment plan called CHART. This trial is supported by Cancer Research UK.

If you have non small cell lung cancer, but cannot have surgery, your doctor may suggest that you have radiotherapy to try and kill off the lung cancer cells. This is called radical radiotherapy. There are 2 ways of having radiotherapy treatment. One is to have radiotherapy every weekday for between 4 and 7 weeks. The other way is to have 3 treatments every day, including weekends, for about 12 days. This is called CHART radiotherapy (Continuous Hyperfractionated Accelerated RadioTherapy’).

We know from research that radiotherapy may work even better if the dose is increased, or ‘escalated’. This study will also use radiotherapy beams that can shape to, or ‘conform’ to the shape of the cancer, helping to avoid healthy tissue (‘conformal radiotherapy’). So it should be possible to give a bigger dose of radiation without increasing serious side effects. The main aims of this study are to

  • See if it is possible to give CHART radiotherapy with higher doses of radiation, and the best dose to give
  • See how well this treatment plan works to treat non small cell lung cancer
  • Learn more about the side effects

Recruitment

Start 01/03/2010
End 09/05/2012

Phase

Phase 1

Who can enter

You can enter this trial if you

  • Have stage 3 non small cell lung cancer
  • Are well enough to take part (performance status 0 or 1)
  • Have been told that your cancer cannot be treated with surgery or you are able to have surgery but have chosen not to
  • Have satisfactory lung function tests
  • Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this study if you

  • Have already had radiotherapy to your chest (thoracic radiotherapy)
  • Have had a section (lobe) of your lung removed (‘lobectomy’)
  • Have had a whole lung removed (‘pneumonectomy’)
  • Have had chemotherapy that treats the whole body (‘systemic chemotherapy’)
  • Have had any other cancer that your doctor believes may affect the study treatment or results
  • Have had a disorder that may cause scarring of your lung tissue (interstitial lung disease)
  • Have had a disease affecting your spinal cord
  • Have a disease that affects the supporting tissues of the body (connective tissue), for example lupus or scleroderma
  • Have another medical condition, for example diabetes, heart disease or a serious infection that is uncontrolled
  • Are pregnant or breastfeeding

Trial design

This study will recruit up to 36 people.

If you are due to have radiotherapy to treat your lung cancer, you first come to hospital to have your radiotherapy planning session. If the session shows that you are suitable to have CHART radiotherapy, you will sign a consent form for this. If you agree to take part in this study, you then sign a separate consent form.

Everyone taking part will have CHART radiotherapy. You have CHART 3 times a day for 12 days in a row, including the weekend.

After this, you will be put into one of 3 groups for the extra study treatment

  • Group 1 will have 2 extra radiotherapy treatments on day 15 (Monday)
  • Group 2 will have 4 extra radiotherapy treatments on days 15
    and 16
  • Group 3 will have 6 extra radiotherapy treatments on days 15,
    16 and 17

You will also have blood tests regularly throughout your treatment.

You will continue to see the study team regularly after you finish the study treatment, for up to 5 years. You will also see your usual cancer doctor in the same way as before the study.

Hospital visits

Before you join the study you will see the doctor and have some tests. These tests include

You will see the study doctor every week during your radiotherapy. After you finish treatment, the study team will follow your progress for 5 years. You will see them

  • Every week for a month
  • Once a month for the next 5 months
  • Every 3 months for the next year and a half
  • Twice in the following year
  • Then once a year for the next 2 years

During the first 2 years you will also have

  • 6 chest X-rays
  • 2 CT scans of your chest
  • 3 lung function tests
  • 2 heart traces (ECGs)

You may have extra tests during this time if your doctor thinks you need them.

Side effects

Researchers think the side effects of the CHART radiotherapy in this study may include

You will have more chest X-rays if you take part in this study than if you were having the standard radiotherapy treatment. But the study team do not think that you would notice any extra problems with your health as a result of this.

You can find out more about the general side effects of lung cancer radiotherapy on CancerHelp UK.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Matthew Hatton

This is Cancer Research UK trial number CRUK/08/017.

Supported by

Cancer Clinical Trials Unit Scotland (CaCTUS)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Sheffield Teaching Hospitals NHS Foundation Trust
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Updated: 23 April 2014