A trial comparing gemcitabine and docetaxel with doxorubicin for soft tissue sarcomas (GeDDiS)

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Cancer type:

Children's cancers
Sarcoma
Soft tissue sarcoma

Status:

Results

Phase:

Phase 3

This trial compared doxorubicin or a combination of docetaxel and gemcitabine as the first treatment for advanced soft tissue sarcoma. It was for people whose sarcoma had spread into the surrounding body tissue, or to other parts of the body. 

The trial closed in 2014 and these results were published in 2017. 

Cancer Research UK supported this trial.

More about this trial

This trial was for children over the age of 13 as well as adults. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
 
Doctors usually treat soft tissue sarcoma with chemotherapy. The drug they most often use is called doxorubicin. This is the standard treatment Open a glossary item.
 
Research has shown that having 2 chemotherapy drugs called docetaxel and gemcitabine could help people with soft tissue sarcoma. In this trial, the researchers wanted to find out if this combination of drugs worked better than the standard treatment.
 
The aims of the trial were to:
  • find out if this combination of drugs worked better than the standard treatment for soft tissue sarcoma that had spread
  • learn more about the side effects

Summary of results

The trial team found that doxorubicin should remain as the standard first treatment for people with advanced soft tissue sarcoma.

This phase 3 trial recruited 257 people. It was a randomised trial. Those taking part were put into 1 of 2 treatment groups.

  • 129 people had doxorubicin
  • 128 people had gemcitabine and docetaxel


 

Results
The main aim of the trial was to find out how many people were alive and had no sign of sarcoma 6 months after finishing treatment. They found there was no difference between the 2 groups. 
 
The team then looked at the overall average length of time people lived after an average follow up of 22 months. They found that it was:
  • just under 73 ½ weeks for those who had doxorubicin
  • just under 67 ½ weeks for those who had gemcitabine and docetaxel
The team also looked at how well the treatment worked. 
 
No sign of the cancer (complete response)
There:
  • were 2 people in the doxorubicin group
  • was no one in the gemcitabine and docetaxel group
Sarcoma had shrunk (partial response)
There were:
  • 23 people in the doxorubicin group
  • 26 people in the gemcitabine and docetaxel group
Sarcoma had stayed the same (stable disease)
There were:
  • 60 people in the doxorubicin group
  • 50 people in the gemcitabine and docetaxel group
Sarcoma continued to grow (progressive disease)
There were:
  • 25 people in the doxorubicin group
  • 27 people in the gemcitabine and docetaxel group
Number of people whose results the team couldn’t get
There were:
  • 19 in the doxorubicin group
  • 26 in the gemcitabine and docetaxel group 
Side effects
The most common side effects in each group were:
  • a drop in blood cells including a drop in white blood cells with a high temperature (febrile neutropenia)
  • loss of hair
  • tiredness (fatigue)
  • feeling sick or being sick
  • sore mouth
  • pain
  • loss of appetite
  • diarrhoea or constipation
Overall people who had gemcitabine and docetaxel had more side effects than those who had doxorubicin. 
 
Conclusion
The trial team concluded that doxorubicin should remain as the first choice of treatment for people with advanced sarcoma. Because although gemcitabine and docetaxel worked just as well there were more side effects. And this could have a big impact on people’s quality of life Open a glossary item
 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) 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.
 

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

Dr Beatrice Seddon

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/10/004.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

5089

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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