
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial looked at adding temozolomide to chemotherapy for people with . It is a type of soft tissue sarcoma.
It was for children and adults whose sarcoma had come back or treatment had stopped working.
The trial was supported by Cancer Research UK.
It was open for people to join between 2012 and 2018. The team published the results in 2021.
This trial was for children over 6 months old and adults up to 50 years old.
There are a number of treatment options for rhabdomyosarcoma. Sometimes the treatment stops working or the cancer comes back afterwards. When this trial was done people may then have had 2 chemotherapy drugs. These are called vincristine and irinotecan.
Doctors were looking for ways to improve this treatment. In this trial, they looked at adding another chemotherapy drug called temozolomide. At the time of the trial it was a treatment for some other cancer types.
The aims of the trial were to:
The team found that adding temozolomide to vincristine and irinotecan improved treatment. Some of the side effects were worse but the team say these were manageable.
Trial design
This was a phase 2 trial. 120 people took part. The age was 11 years old.
People were put into a treatment group at random:
Everybody taking part had up to 12 for as long as it was working and the side effects weren’t too bad. Each cycle of treatment was 3 weeks.
Results
The trial team followed everyone up for about 57 months. They looked at how well treatment worked.
In the vincristine and irinotecan group the researchers had the results for 58 people. They found the cancer:
In the VIT group the researchers had the results for 58 people. They found the cancer:
The researchers looked at how long before the cancer started to grow again. They found it was:
They also looked at how long people lived. They found it was:
Side effects
Everybody had at least one side effect. The most common severe side effects were:
A few more people who had VIT had these side effects.
We have information about:
Conclusion
The team concluded that temozolomide, vincristine and irinotecan improved treatment for rhabdomyosarcoma that had come back. It increased the length of time that people lived.
Vincristine, irinotecan and temozolomide may now be the new for this group of people.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Julia Chisholm
Cancer Research UK
Cancer Research UK Children's Cancer Trials Team
Centre Oscar Lambret
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/11/019.
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”