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

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

Study diagram

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.