A trial looking at doxorubicin alone or ifosfamide with doxorubicin for advanced soft tissue sarcoma (EORTC 62012)

Who can enter

You can enter this trial if you

• Have been diagnosed with grade 2 or 3soft tissue sarcoma, including malignant fibrous histiocytoma, liposarcoma, uterine leiomyosarcoma, pleomorphic rhabdomyosarcoma, synovial sarcoma, myxofibrosarcoma, fibrosarcoma, leiomyosarcoma, angiosarcoma, malignant peripheral nerve sheath tumour and epithelioid sarcoma
• Have sarcoma that has spread to another part of your body (apart from to the brain)
• Have sarcoma that cannot be removed with surgery
• Are well enough to have chemotherapy (performance status 0 or 1)
• Have satisfactory blood test results
• Are between 18 and 60 years old

You cannot enter this trial if you

• Have been diagnosed with GIST, mixed mesodermal tumour, chondrosarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewings sarcoma, primitive neuroectodermal tumour (PNET), desmoplastic small round cell tumour, embryonal rhabdomyosarcoma or alveolar soft part sarcoma
• Have soft tissue sarcoma that has spread to your brain
• Have had chemotherapy before for soft tissue sarcoma that has spread
• Have had any other cancer in the past (apart from carcinoma in situ of the cervix or basal cell skin cancer that was successfully treated)
• Have any other serious medical condition
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. The people taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This trial will recruit 450 patients. There are 2 groups.

If you are in group 1 you will have doxorubicin chemotherapy. You will have chemotherapy once every 3 weeks as a drip into a vein. You will either have this over about 20 minutes on one day. Or more slowly over 3 days (72 hours) through a central line.

If you are in group 2 you will have chemotherapy for 4 days every 3 weeks. You will have the ifosfamide once a day for the 4 days. This will take about 4 hours each time. You will have doxorubicin once a day for 3 out of the 4 days. This will take about 20 minutes each time.

The same dose of doxorubicin will be given to you whichever group you are in, but if you are in group 2 it is split into 3 smaller doses.

If you are in group 2, you will also have an injection into your skin of a growth factor called GCSF on day 5 of each cycle. Chemotherapy can cause the number of blood cells to drop. GCSF stimulates the growth of blood cells, so helps the blood cells recover from chemotherapy more quickly.

You will be given chemotherapy up to 6 times (6 cycles). But the exact number of cycles you have depends on how well the treatment works. If it works very well, your doctor may decide to give you more than 6 cycles.

Hospital visits

You will see the doctors at the hospital and have some tests before you can take part in this trial. The tests include

• Blood tests
• Urine tests
• Either a MUGA scan or echocardiogram of your heart
• A chest X-ray
• Either a bone scan or X-rays of your bones
• A physical examination
• Either a CT scan or an MRI scan.

You will have blood tests and a physical examination before each cycle of chemotherapy. You will have an X-ray and either a CT scan or MRI scan after cycles 2, 4 and 6.

When you have finished chemotherapy you will see the doctors every 2 months until your sarcoma starts to grow again. After that you will see the doctors every 3 months.

Side effects

The most common side effects of ifosfamide are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Hair loss

The most common side effects of doxorubicin are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Hair loss
• Sore mouth (mucositis)

There is more information about the side effects of both ifosfamide and doxorubicin in the chemotherapy section of the CancerHelp UK website.