A trial looking at mitotane for adrenal gland cancer (ADIUVO)

Cancer type:

Adrenal gland cancer

Status:

Results

Phase:

Phase 3

This trial looked at mitotane after surgery for adrenal gland cancer. It was for people who had a small chance that the cancer could come back. 

The trial was supported by Cancer Research UK. It was open in the UK for people to join between 2014 and 2017. The team presented the results at a conference in 2022.

More about this trial

Doctors treat adrenal gland cancer with surgery. Treatment after surgery depends on how likely it is that the cancer will come back.

When this trial was done, people had mitotane if doctors thought there was a high chance that the cancer would come back. But they weren’t sure whether it was best to give chemotherapy to people who had a low or medium risk of their cancer coming back. They don’t want to give people treatments they don’t need.

Some people in this trial had mitotane after surgery, and some didn’t. Those who didn’t, had regular check ups and tests to look for signs of the cancer coming back.

The main aim of this trial was to find out whether mitotane can help stop low risk adrenal cancer coming back after surgery.

Summary of results

Trial design
This trial was for people with adrenal gland cancer who had:

  • already had surgery to remove the cancer
  • a low or medium chance that their cancer would come back

Some people had mitotane after their operation. They took mitotane tablets 3 times a day for up to 2 years.

Some people didn’t have mitotane after their operation. 

Everyone taking part had regular appointments and scans to check for any signs that their cancer had come back. The research team compared the results for the 2 groups.

Results
There were 91 people in this trial:

  • 45 people had mitotane
  • 46 people didn’t have mitotane

The research team looked at how many people’s cancer started to grow again. They found it was similar in the two groups:

  • 8 out of 45 people who had mitotane
  • 11 out of 46 people who didn’t have mitotane 

They also looked at how many people had died. They found it was low in both groups:

  • 2 out of 45 people who had mitotane
  • 5 out of 46 people who didn’t have mitotane

Side effects
We have been unable to find information about the side effects that the people who took part in this trial had.

We have general information about mitotane, including details of the usual side effects, in our Cancer drugs section. The most common side effects are:

  • loss of appetite
  • feeling or being sick
  • diarrhoea
  • extreme tiredness (fatigue)

Conclusion
The trial team found that a small number of people with adrenal gland cancer have a low or medium risk that their cancer will come back. They also found that these people tend to do better than they expected. And that there is no benefit in them having mitotane.

The trial team don’t recommend that mitotane is used as a treatment for this group of people. But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below. 

Please note, this article may not be in plain English. It has been written for health care professionals and researchers.

First randomized trial on adjuvant mitotane in adrenocortical carcinoma patients: The Adiuvo study.
A Berruti and others
Journal of Clinical Oncology, 2022. Volume 40, Issue 6.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Wiebke Arlt

Supported by

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

Other information

This is Cancer Research UK trial number CRUK/12/018.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9538

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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