Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at different treatments for people with oropharyngeal cancer (CompARE)
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This trial is for people who have intermediate or high risk oropharyngeal cancer. Cancer Research UK supports this trial.
Oropharyngeal cancer is cancer of the middle part of the throat (the oropharynx). The oropharynx includes:
- the back third of your tongue
- the soft area at the back of the roof of the mouth (the soft palate)
- the tonsils and two ridges of tissue in front of and behind the tonsils
- the back wall of your throat
More about this trial
Doctors divide oropharyngeal cancer into 3 main types. These are low, intermediate, and high risk. Doctors think about half of these cancers have the Human Papilloma Virus (HPV) in them.
Intermediate risk oropharyngeal cancer can be caused by HPV being present and by smoking. Higher risk oropharyngeal cancers are those caused by high levels of tobacco smoking or alcohol intake, and are not due to HPV being present. Higher risk oropharyngeal cancers don’t respond as well to standard treatment as low risk oropharyngeal cancer.
Doctors usually treat oropharyngeal cancer with a combination of the chemotherapy drug cisplatin and radiotherapy. This is called chemoradiotherapy. In this trial doctors want to compare this treatment with 4 other treatments to see which is best for people with intermediate and high risk oropharyngeal cancer. They also want to find out how the treatment might affect your day to day life.
Who can enter
You may be able to join this trial if all of the following apply. You:
- have been diagnosed with an oropharyngeal squamous cell cancer in the base of your tongue and tonsil and your doctors have recommended chemoradiotherapy
- have a cancer that is considered to be intermediate or high risk (your doctors can advise you about this)
- have satisfactory blood test results
- are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance that you or your partner could become pregnant
- weight more than 30kg (4st 7lb)
- are aged between 18 and 70
You cannot join this trial if any of these apply. You:
- have been diagnosed with low risk oropharyngeal cancer
- are unable to have either surgery or chemoradiotherapy
- have had any other chemotherapy, immunotherapy or anti cancer drugs in the last 3 weeks
- have had treatment with an experimental drug in the last 30 days
- have had major surgery in the last 4 weeks
- have significant side effects from previous treatment (except hair loss)
- have problems with your kidneys
- have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or a type of skin cancer called basal cell carcinoma that was successfully treated
- are allergic to any of the drugs used in this trial
- are pregnant or breastfeeding
You cannot join one of the treatment groups if the following also apply. You:
- have already had durvalumab or another drug that works in the same way
- have taken in the past 2 weeks drugs that damp down the immune system, such as steroids, apart from nose sprays, inhalers or a low daily dose of steroids
- have, or had in the past, an autoimmune disease such as lupus erythematosus
- have an inflammatory bowel disease such a Crohn’s, irritable bowel syndrome or coeliac disease
- have inflammation of the lungs
- have a condition where part of the immune system is missing or it isn’t working properly
- have had an organ transplant
- have had tuberculosis (TB)
- have had a live vaccination within 30 days before agreeing to take part in this trial
If you are not able to have surgery for any reason you may still be able to take part in the trial. You will only be able to take part in the treatment groups that do not involve surgery. Your doctors can advise you.
This is a phase 3 trial. The researchers need 695 people to join. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
People will be put into 1 of 4 treatment groups:
- cisplatin and radiotherapy (chemoradiotherapy)
- docetaxel, cisplatin and 5-fluorouracil chemotherapy followed by chemoradiotherapy. Please note this group is now closed
- high dose radiotherapy and cisplatin. Please note this group is now closed
- surgery followed by chemoradiotherapy Please note this group is now closed
- durvalumab and chemoradiotherapy followed by durvalumab
If you are not able to have surgery for any reason then you are put into one of the other treatment groups. Your doctor can discuss this with you. You may be offered the drug carboplatin instead of cisplatin if the doctors think this would be a better choice for you.
Cisplatin and radiotherapy (chemoradiotherapy)
If you are in the group having chemoradiotherapy, you have cisplatin as a drip into your vein. You have cisplatin once every 3 weeks. You have it 3 times. Each time is called a cycle of treatment. Or you have cisplatin once a week for 7 weeks.
You have radiotherapy once a day Monday to Friday over 7 weeks.
High dose radiotherapy and cisplatin
This is similar to the group having chemoradiotherapy but instead of having treatment over 7 weeks you have treatment over 5 weeks. You have cisplatin once on the first day of week 1 and then again on the first day of week 5. Or you have cisplatin once a week for 5 weeks.
Surgery followed by chemoradiotherapy
You may have either laser or robotic surgery to remove the cancer. If this is not possible you will have open surgery. This means the surgeons will need to make an opening (incision) to remove the cancer. You may also need lymph nodes removed. This is called a neck dissection. Your doctors will explain what will be involved if you have surgery.
About 6 weeks after surgery you have chemoradiotherapy as described above.
Durvalumab and chemoradiotherapy followed by durvalumab
Durvalumab is an immunotherapy. It helps the body’s immune system recognise and kill cancer cells.
You have a single dose of durvalumab as a drip into a vein before starting chemoradiotherapy. You have chemoradiotherapy as in group 1:
- cisplatin every 3 weeks (3 times) or once a week for 7 weeks
- radiotherapy Monday to Friday for 7 weeks
After chemoradiotherapy you have durvalumab every 4 weeks for 6 months.
The trial team asks everyone taking part in the trial to fill out various questionnaires. This will be before you start treatment, during treatment and at different times after you finish treatment.
One questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Another questionnaire asks about your swallowing. This is called a swallowing assessment questionnaire.
You might also be asked to complete a questionnaire about whether your cancer and treatment has affected your finances. The researchers want to see if any of the treatments cause a financial burden. This questionnaire is called a cost effectiveness questionnaire.
You are asked if you would be willing to give samples of your blood and spit (oral fluid). The doctors want a sample of your tissue (a biopsy) taken either when you were diagnosed or when you had surgery. These samples will be used by researchers to try and learn more about how the cancer cells work and what effect the drugs have on them. You do not have to give these samples if you don’t want to. You can still take part in the trial.
You see the doctors and have some tests before you start treatment. The tests include:
For people having durvalumab you also have a urine test and heart trace (ECG).
The amount of visits and time in hospital will depend on what treatment group you are in.
After you finish treatment you see the doctors every month for the first year and then every 2 months in the second year. You have blood tests at these appointments and the doctors ask how you are. After 2 years you see the doctor once a year for 5 years.
3 months after you finish treatment you have either a CT, MRI or PET-CT scan. If the doctors find any cancer in your neck on these scans you have surgery.
The side effects you have will depend on which treatment group you are in. Your doctors will explain what side effects you can expect from your treatment.
The common side effects of radiotherapy to your head and neck include:
- sore mouth causing pain and difficulty swallowing
- taste changes
- feeling sick
- sore skin
- thicker spit
- hair loss in the area where the radiotherapy is given
We have information on the side effects of having radiotherapy to your head and neck.
The most common side of durvalumab include
- skin rash and, or dry itchy skin
- feeling or being sick
- loss of appetite
- shortness of breath
- high temperature (fever)
- tummy (abdominal) pain
- infection of the nose, throat and upper chest
The most common side effects of the chemotherapy drugs used in this trial include
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- feeling or being sick
- sore mouth and mouth ulcers
- loss of appetite
- tiredness and weakness (fatigue)
We have information about
Your doctor will talk to you about the side effects of your treatment before you agree to take part.
How to join a clinical trial
Professor Hisham Mehanna
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/13/026.