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A trial looking at standard radiotherapy and intensity modulated radiotherapy for people with parotid gland cancer (COSTAR)

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

This trial is comparing standard radiotherapy with a new type of radiotherapy called Intensity Modulated Radiotherapy (IMRT) for cancer of the parotid glands. This trial is supported by Cancer Research UK.

The parotid glands are a type of salivary gland found just under the earlobes. Salivary gland cancer is a very rare type of head and neck cancer. Doctors usually treat it with surgery and radiotherapy.

Standard radiotherapy for parotid gland cancer may cause damage to the inner ear and hearing loss. IMRT shapes both the beam and the dose of radiation to match the shape of the tumour. This allows the radiographer to target the radiation beams more accurately at the area of cancer. This reduces the risk of damaging surrounding healthy tissue. So doctors think that this may reduce hearing loss. But there is a small risk that IMRT will miss some of the cancer and so may not work so well.

The aims of the trial are find out

  • If IMRT reduces hearing loss compared to standard radiotherapy
  • How well IMRT works for parotid gland cancer
  • More about side effects and quality of life

Recruitment

Start 29/08/2008
End 31/01/2013

Phase

Phase 3

Who can enter

You can enter this trial if you

  • Have parotid gland cancer
  • Have a high risk of developing hearing loss with standard radiotherapy - your doctor can tell you more about this
  • Are due to have radiotherapy after surgery
  • Are well enough to take part (performance status 0 or 1)
  • Are at least 18 years old

You cannot enter this trial if you

  • Have already had radiotherapy to your head and neck
  • Are not having surgery as first treatment
  • Already have hearing loss that is greater than 60dB - you can check this with your doctor
  • Are due to have chemotherapy and radiotherapy at the same time
  • Have cancer that started somewhere else in the body and spread to the parotid glands
  • Have any other medical condition which means you cannot take part in this trial

Trial design

This phase 3 trial will recruit 84 people. It is a randomised trial. The people taking part are put into 2 different groups by computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have standard radiotherapy. If you are in group 2 you will have intensity modulated radiotherapy (IMRT). Both IMRT and standard radiotherapy involve the same number of treatment sessions. The difference is in the way the radiotherapy is planned. But your trial doctor can tell you more about this.

You will fill in a questionnaire at the beginning of the trial and again

  • After 6 months
  • After 1 year, 2 years and 5 years

The questionnaire will ask you about any side effects you have and how you have been feeling. This is called a quality of life questionnaire.

Hospital visits

Before you start treatment, your doctor will examine you and you will have some tests. These include

  • A CT scan or MRI scan of your head and neck
  • CT scan of your chest
  • Chest X ray
  • Dental check up
  • Hearing test
  • Test of the inner ear that helps maintain balance (vestibular function)
  • Blood tests

You will also have a radiotherapy planning session.

You will have IMRT or standard radiotherapy at the hospital as an outpatient. The treatment itself only takes a few minutes. Everyone will have treatment once a day, Monday to Friday, for 6 weeks.

During treatment you will see a doctor every week. They will examine your radiotherapy site and ask if you have any side effects.

6 months and a year after treatment has finished, you go to the hospital to have your hearing and balance tested. These tests will be repeated after 1 year, 2 years and 5 years.

Side effects

All treatments have side effects. The side effects of radiotherapy vary depending on which area of the body is being treated. Both IMRT and standard radiotherapy have the same side effects.

The most common short term side effects of radiotherapy may include

  • Sore skin and a sore throat
  • A dry mouth or sore mouth
  • Tiredness
  • Taste changes
  • Hearing problems
  • Hair loss to the treatment area

You can read more about the side effects of radiotherapy for head and neck cancer.

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

Prof Chris Nutting

This is Cancer Research UK trial number CRUK/08/004.

Supported by

Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)
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Updated: 31 January 2013