Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study looking at increasing the dose of radiotherapy to treat cancer of the voice box or lower part of the throat (ART DECO)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is comparing standard and higher doses of intensity modulated radiotherapy for cancer of the voice box (cancer of the larynx) or hypopharynx. The
The treatment you have for cancer of the larynx or hypopharynx depends on exactly where the cancer is and how much it has grown and spread. You may have a combination of surgery, radiotherapy and chemotherapy. One type of radiotherapy is called intensity modulated radiotherapy (IMRT). With IMRT, the radiotherapy beams are shaped so they target your cancer, but cause less damage to healthy tissue around it. Doctors may combine IMRT with a course of chemotherapy. But IMRT does not always get rid of the cancer completely, even when combined with chemotherapy.
This study is looking at giving a higher dose of IMRT. The study will compare the standard IMRT dose with a higher dose. They will look at how well the higher dose works, and at the side effects, to find the best dose they can give in future. The main aim of this study is to see if it is possible to improve IMRT to cancers of the larynx and hypopharynx by increasing the dose of radiotherapy while still avoiding damage to healthy tissue.
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
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.
If your general health is good enough you may also have a dose of cisplatin chemotherapy at the start and end of your IMRT, whichever group you are in. This is separate to the chemotherapy some people may have had before starting their IMRT. 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.
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
- 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.
If you are having the cisplatin chemotherapy at the start and end of your course of IMRT, you have this when you are already at the hospital for your radiotherapy. Depending on your hospital, you may have the cisplatin over 1 or 2 days at the start and end of your IMRT.
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
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
- 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.
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.
Prof Christopher Nutting
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The National Health Service Research and Development Executive
The Royal Marsden NHS Foundation Trust
This is Cancer Research UK trial number CRUK/10/018.