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

This trial is looking at having either doxorubicin or a combination of 2 drugs called docetaxel, and gemcitabine as the first treatment for advanced soft tissue sarcoma. It is for people who have sarcoma that has spread into surrounding body tissue, or to other parts of the body. The trial is funded by Cancer Research UK.

This trial is for children over the age of 13 as well as adults. We use the term ‘you’ in this summary, but of course 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.

We know from research that having 2 chemotherapy drugs called docetaxel and gemcitabine can help people with soft tissue sarcoma. But in this trial, the researchers want to find out if this combination of drugs works better than the standard treatment.

The aims of the trial are to

Find out if this combination of drugs works better than the standard treatment for soft tissue sarcoma that has spread
Learn more about the side effects

Recruitment

Start 25/11/2010

End 25/11/2013

Phase

Phase 3

Who can enter

You can enter this trial if you

Have soft tissue sarcoma that has spread into surrounding body tissue or to other parts of the body, and cannot be treated with surgery or radiotherapy
Have sarcoma that has grown in the last 6 months
Are well enough to be up and about for at least half the day (performance status 0, 1, or 2)
Have a tumour that can be seen on a CT scan or MRI scan
Are at least 13 years old
Have satisfactory blood test results
Have satisfactory results of a scan to see how well your heart is working (echocardiogram or MUGA)
Are willing to use reliable contraception during the trial and for 6 months after treatment if there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

Have one of the following rare types of sarcoma – alveolar soft part sarcoma, GIST (gastrointestinal stromal tumour), Ewing’s sarcoma, alveolar or embryonal rhabdomyosarcoma, desmoplastic small round cell tumour, extra-skeletal myxoid chondrosarcoma, dermatofibrosarcoma protuberans, mixed mesodermal tumour/carcinosarcoma of the uterus, or a smooth muscle tumour of uncertain malignant potential (STUMP)
Have already had chemotherapy to treat soft tissue sarcoma
Have had doxorubicin to treat any other type of cancer in the past
Have sarcoma that has spread to the brain
Have any other serious medical conditions
Have an infection that cannot be controlled with medication
Have had another cancer in the last 3 years except for non melanoma skin cancer or carcinoma in situ of the cervix, prostate or breast
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit about 250 people in the UK and other countries. This will take about 3 years.

It is a randomised trial.The people taking part will be put into 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

People in group 1 have doxorubicin through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment.

People in group 2 also have chemotherapy through a drip into a vein in 3 week cycles of treatment. They have gemcitabine on day 1, then gemcitabine and docetaxel on day 8.

People in both groups have up to 6 cycles of treatment, lasting about 4 or 5 months in total.

You will also be asked to fill out a questionnaire before you start treatment, then after 12, 18, and 24 weeks. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask your permission to take an extra blood sample before you start treatment. You do not have to give this extra sample for research if you do not want to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests may include

Blood tests
Physical examination
Heart ultrasound (echocardiogram) or MUGA scan
CT scan
MRI scan

On day 1of each treatment cycle you have

Blood tests
Physical examination
Chemotherapy

People in group 2 also have a blood test and chemotherapy on day 8 of each cycle. You will not need to stay in hospital overnight.

During the trial you have a CT scan about every 12 weeks until your disease starts to grow again.

When you finish treatment you will see the trial doctors again 6 weeks later and have a blood test. A member of the trial team will then phone you every 3 months to see how you are.

Side effects

The most common side effects of doxorubicin are

Hair loss
A drop in blood cells which can cause an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Diarrhoea
Sore mouth

The most common side effects of gemcitabine and docetaxel are