A trial looking at a new method of radiotherapy versus standard radiotherapy for head and neck cancers (PARSPORT)

This trial is comparing a new type of radiotherapy treatment called Intensity Modulated Radiotherapy (IMRT) with the standard radiotherapy treatment for head and neck cancers.

Radiotherapy can be given on its own, or after surgery, to treat people with head and neck cancers. But radiotherapy has side effects. The radiotherapy can often affect the working of the salivary glands, causing a very dry mouth. Other side effects include a sore throat and problems with swallowing.

The new method is called Intensity Modulated Radiotherapy, or IMRT for short. IMRT alters the radiotherapy dose depending on the thickness of the body tissue. So the same dose is given across the treatment area. It also allows the radiotherapy beams to be shaped more accurately. It is directed at the cancer, while avoiding the surrounding normal tissue. So, the patient may have fewer side effects. But there is a small risk that this shaped radiotherapy will miss some of the cancer and so may not work so well.

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/06/2003

End 31/12/2007

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with squamous cell or undifferentiated cancer cancer of the oropharynx or hypopharynx
Have a cancer that is smaller than 10cm and has not spread to another part of your body (it can have spread to your lymph nodes)
Are well enough to take part in the trial

You cannot enter this trial if you

Have cancer of the larynx or oral cavity (mouth)
Have a cancer that is larger than 10cm
Have already had radiotherapy treatment for your cancer
Have had any other type of cancer in the past, except non-melanoma skin cancer
Have a medical condition or illness that you would prevent you from having radiotherapy treatment
Are currently having chemotherapy
Are taking amifostine or pilocarpine for your dry mouth (as this would affect the results of the study)

Trial design

This trial is recruiting 100 patients. There are 2 treatment groups. It is a randomised trial. This means that the people taking part will be put into the groups by a computer.

Group 1 will have standard radiotherapy treatment. Group 2 will have IMRT.

Your first visit to the radiotherapy department will involve the planning of your treatment. Your treatment will probably involve having 30 daily treatments, from Monday to Friday, over a period of 6 weeks.

Hospital visits

Before your treatment, your doctors will need a tissue sample of your cancer. This will be taken at the time of your surgery. Or if you have not had surgery, you will have a biopsy of your cancer. You will have various tests before your treatment starts. These tests will include a chest X-ray and a CT or a MRI scan of your cancer. You will also have salivary flow measurements and blood tests.

To have your radiotherapy treatment, you will need to travel to your nearest radiotherapy centre every weekday. If you are not able to travel by yourself or a friend or relative cannot take you, the hospital may be able to provide you with hospital transport.

When your treatment has finished, your consultant will want to see you every week for the 1st month, monthly for the 1st year and then every 8 weeks during the 2nd year. Your doctor will examine you and ask if you have had any problems.

Every 3 months after your treatment, you will have an assessment of your salivary flow. This will be done by a dentist at your hospital.

You will also be asked to answer a number of questions at the start of the trial. This is called a quality of life questionnaire. This will be repeated after your treatment at 2 weeks, then after 3, 6 12, 18 and 24 months. The researcher will ask you if you have been having any side effects and will ask how have been feeling.