A study looking at increasing the dose of radiotherapy to treat cancer of the voice box or lower part of the throat (ART DECO)

Who can enter

If you are suitable for this study, your doctor will ask if you would like to take part. People taking part will

• Have squamous cell cancer of the larynx or hypopharynx that is locally advanced (stage 3 or 4 a or b)
• Be well enough to carry out all normal activities, apart from heavy physical work (performance status of 0 or 1)
• Have kidneys that work well enough to take part
• Be able to come to the hospital for study visits over the next 5 years
• Be at least 16 years old

You cannot enter this trial if you have

• Cancer of the larynx or hypopharynx that needs surgery
• Already had radiotherapy to your head or neck
• Cancer that has spread to another part of the body
• Had any other cancer, apart from non melanoma skin cancer or another early stage cancer that has been successfully treated and not come back in the last 5 years
• Speech or swallowing problems not related to your cancer
• Had any other condition which may stop you having all the study treatment– you can check this with your doctor

Trial design

This study will recruit 354 people. It is randomised study. The people taking part are put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Before you start the study, your doctor may want you to have a course of chemotherapy. This is not part of the study. Your doctor will tell you more about this if it applies to you.

Once you have had any chemotherapy your regular doctor wants you to have, you will start the study treatment.

If you are in group 1, you will have standard IMRT. You have one dose (‘fraction’) of IMRT each weekday, 5 days per week. You have 30 fractions of IMRT altogether.

If you are in group 2, you will have the higher dose of IMRT. You have one fraction of higher dose IMRT each weekday, 5 days per week. You have 28 fractions of IMRT altogether.

Each treatment session for both groups will take about 30 minutes. The treatment only lasts a few minutes, but you will lie on the radiotherapy couch for longer as the machine moves around to give the radiotherapy from different angles.

Both groups will also have a dose of cisplatin chemotherapy at the start and end of their IMRT. This is separate to the chemotherapy some people may have had before starting their IMRT. The dose is the same for each group. You have cisplatin through a drip into a vein.

You will have regular tests and check ups during and after the study treatment.

You will also be asked if you would be willing to take part in extra research linked to the main study. The first type of research is a quality of life study. Everyone willing to take part will be asked to fill out a questionnaire before and after treatment, at 6 months and then every year for 5 years. The questionnaire will ask about any side effects you have had and about how you have been feeling. You complete the first questionnaire and the end of treatment questionnaire at the hospital, and the trials office will post the other questionnaires to you at home for you to complete and return in a prepaid envelope. The questionnaires will take between 20 and 40 minutes to complete.

The team will also ask if you would be willing to give a sample of blood, and permission for them to use a sample of tissue you have already had removed.

They will use the tissue sample for future research into the effects of radiotherapy on cancer tissue. They will use the blood sample to find out why some patients are more sensitive to radiotherapy than others. They want to see if they can use these differences to work out who may have more side effects from radiotherapy. In future, they may then be able to adjust the dose more closely to the individual patient.

You do not have to take part in these extra parts of the study if you don’t want to. You can still take part in the main study.

Hospital visits

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

• CT scan or MRI scan of the head and neck
• CT scan of your chest, or a chest X-ray
• Blood tests
• Check up of your teeth and mouth
• Quality of life questionnaire (if you are taking part in the quality of life study)

After you have had your radiotherapy planning, you come to the hospital 28 or 30 times for radiotherapy, depending on which group you are in. You will have your study cisplatin chemotherapy at the start and end of your course of IMRT, when you are already at the hospital for your radiotherapy.

You will see the study team every week during treatment and have a blood test. After treatment you will see the study team after 1, 2, 3, 4 and 8 weeks.

You will have a CT or MRI scan 2 to 3 months after you finish treatment.

You then return to the hospital

• 3 months after treatment
• Every 3 months up to 2 years
• Every year, up to 5 years since you finished treatment

Side effects

If you are in the group having the higher dose of IMRT radiotherapy, you may have more side effects than people having the standard dose. The researchers do not know if this will be the case, and this is one of the reasons for the study.

Side effects of all radiotherapy to the neck, including IMRT, include

• Tiredness
• Sore red skin to the area being treated
• Weight loss
• A sore throat and mouth (your throat may become more sore as you go through treatment)
• Pain and difficulty swallowing
• Dry mouth
• Loss of taste
• Hoarse voice

Side effects will slowly improve and usually get better within 2 to 3 weeks of finishing radiotherapy. But as you will be having cisplatin chemotherapy at the same time as IMRT, the soreness may take up to 3 months to settle in some people.

You can find out more about cisplatin chemotherapy on CancerHelp UK.