"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of bevacizumab and chemotherapy for children and teenagers with soft tissue sarcoma (BERNIE)
This trial looked at a drug called bevacizumab (also known as Avastin) and chemotherapy for soft tissue sarcoma. It was for children and young adults up to the age of 18 who:
- had soft tissue sarcoma that had spread to other parts of the body (metastatic)
- were going to have treatment for metastatic soft tissue sarcoma for the first time
We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
More about this trial
In this trial, researchers wanted to see if adding a drug called bevacizumab to chemotherapy, is better than chemotherapy alone.
The aim of this trial was to see if bevacizumab with chemotherapy is better than chemotherapy alone for children and young adults with metastatic soft tissue sarcoma.
Summary of results
The trial team concluded that adding bevacizumab to chemotherapy in children and young adults with soft tissue sarcoma that has spread didn’t work any better than chemotherapy alone.
This was a phase 2 trial. 154 children and young adults with metastatic soft tissue sarcoma took part. Everyone was having treatment for the first time, after their cancer spread to other parts of the body.
This was a randomised trial. Everyone was put into 1 of the following treatment groups by computer:
- 80 children and young adults had chemotherapy
- 74 children and young adults had chemotherapy and bevacizumab
Neither they nor their doctor could choose which group they were in.
Everyone had chemotherapy in cycles of treatment. The number of treatments people had, depended on their needs and the side effects. On average, children and young adults had treatment for about 18 months.
The trial team looked at how well bevacizumab worked. To do this, they looked at the average amount of time people lived without any signs of their cancer getting worse. They found it was:
- almost 15 months (14.9 months) in the chemotherapy group
- about 20 and a half months (20.6 months) in the chemotherapy and bevacizumab group
The team also looked at the most common side effects. They were:
- a drop in the number of blood cells causing an increased risk of infection, breathlessness and bleeding
- decreased appetite
- low levels of potassium in the blood
- mouth sores
The side effects were similar in both groups.
The team thinks that this trial did not show strong evidence that adding bevacizumab to chemotherapy improves the average amount of time people live without any signs of their cancer getting worse. In other words, it wasn’t
They also concluded that chemotherapy with bevacizumab is a safe treatment for children and young adults.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Dr Julia Chisholm
European Paediatric Soft Tissue Sarcoma Study Group (EpSSG)