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 mitotane for adrenal gland cancer (ADIUVO)
This trial is looking at how well the chemotherapy drug mitotane (pronounced my-toe-tain) works for people with adrenal gland cancer. It is for people who have had surgery to remove their cancer and there is a small chance that the cancer could come back. This trial is supported by Cancer Research UK.
Doctors treat adrenal gland cancer with surgery to remove the adrenal gland. A doctor called a
If there is a high chance that your cancer may come back, you will have mitotane chemotherapy. But if the chances are small or very small, then doctors don’t know if it is better for you to start mitotane or to be monitored closely. The researchers want to find out which might be best for people in this situation.
In this trial, half the people will have mitotane after surgery to remove their cancer and half will be closely monitored.
The aims of this trial are to compare these 2 groups to find out
- How long people live without a sign of their cancer coming back
- How long people live overall
- How treatment or monitoring affect
quality of life
- More about the side effects of mitotane
Who can enter
You may be able to join this trial if all of the following apply
- You have adrenal gland cancer that has been completely removed with surgery
- There is a small or very small chance of your cancer coming back (your doctor can tell you this)
- You have had a scan in the past 4 weeks that shows no signs of cancer
- You have satisfactory blood test results
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are at least 18 years old
For women, if there is any chance that you could become pregnant, you must be willing to use reliable contraception during treatment and for a period of time afterwards. Your doctor will talk to you about how long this may be.
You cannot join this trial if any of these apply
- Your surgery was more than 3 months before you are put into your treatment group in this trial
- You have had surgery again because your cancer came back
- You have had radiotherapy for adrenal gland cancer
- You have had chemotherapy for your cancer
- You have had any other cancer apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated or any other cancer that was successfully treated and there has been no sign of it for the past 3 years
- You are pregnant or breastfeeding
This is an international phase 3 trial. The researchers need 200 people to join the trial.
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 in group 1 have mitotane
- People in group 2 are closely monitored
Mitotane is a tablet. You take it 3 times a day. You take the tablets with a glass of water during or at the end of your meal. Your meal needs to include a fat rich food, such as milk, chocolate or oil. Your doctor will tell you how many tablets you need to take.
You continue taking mitotane for 2 years as long as it is helping you and the side effects aren’t too bad.
While taking mitotane you also need to take
There are some foods you must not eat or drink and certain drugs you must not take when having mitotane. Your doctor will talk to you about this.
The trial team will ask you to fill out a questionnaire before you start treatment, every 3 months during treatment and then every 6 months for 3 years after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask for blood samples and urine samples. You must agree to these if you want to take part in the trial. They will also ask for samples of spit (saliva). These are optional you don’t have to give them if you don’t want to. They will use these samples to find out more about adrenal gland cancer.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor every 3 months for the same tests apart from the heart trace.
After treatment you see the doctor every 6 months until it is 5 years since you joined the trial. You then see the doctor once a year. You have the same tests at each visit, apart from the heart trace.
The most common side effects of mitotane are
- Loss of appetite
- Feeling or being sick
- Numbness or tingling in fingers or toes (pins and needles)
- Difficulty with coordination and movement
- Confusion and difficulty thinking
- Dizziness and loss of balance
- Sore mouth
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Tiredness and feeling sleepy
- Muscle weakness
- Breast tenderness and swelling in men
- Rise of cholesterol in your blood
- Stomach pain
- Minor changes to the way your liver works
Your doctor will talk to you about the possible side effects before you take part in the trial.
We have information on mitotane.
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.
Professor Wiebke Arlt
Cancer Research UK
ENSAT (European Network for the Study of Adrenal Tumours)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/12/018.