A trial looking at eribulin and dacarbazine in sarcoma

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Soft tissue sarcoma




Phase 3

This trial is comparing the chemotherapy drugs eribulin and dacarbazine for people with soft tissue sarcoma that has come back after treatment.

Soft tissue sarcomas are a type of cancer that starts in the supporting tissues of the body, such as muscles, blood vessels, fat and nerves. Doctors usually treat soft tissue sarcoma with surgery and chemotherapy. Sadly the cancer can come back and when this happens it is often more difficult to treat.

Doctors know that eribulin can help people with breast cancer that has come back following treatment. In this trial doctors want to see if eribulin can help people with sarcoma that has come back (recurred). Doctors want to compare it to the standard treatment Open a glossary item of dacarbazine.

The aims of this trial are to find out

  • If eribulin is better than dacarbazine for people with soft tissue sarcoma that has come back after earlier chemotherapy
  • About the side effects

Who can enter

You may be able to enter this trial if you

  • Have adipocytic sarcoma or leiomyosarcoma that is intermediate or high grade and has spread into surrounding tissue or to other parts of your body, and cannot be treated with surgery or radiotherapy
  • Have had at least 2 courses of chemotherapy
  • Have soft tissue sarcoma that has grown in the last 6 months
  • Have an area of soft tissue sarcoma that measures at least 1 cm (or 1.5 cm if a lymph node Open a glossary item) on a CT scan or MRI scan
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception while you are having trial medication and for up to 6 months after finishing trial medication if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have had any treatment for your soft tissue sarcoma in the last 3 weeks
  • Have had treatment on a trial in the last 4 weeks
  • Still have side effects from previous treatment unless they are mild
  • Have had dacarbazine in the past
  • Have been on a trial with eribulin
  • Have had radiotherapy to more than a third your bone marrow Open a glossary item
  • Have had surgery in the last 3 weeks
  • Have numb fingers that cause you a problem
  • Have certain heart problems
  • Have cancer in your central nervous system (CNS) Open a glossary item
  • Have any other illness that is a cause for concern
  • Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 5 years ago
  • Are allergic to dacarbazine, or eribulin
  • Are pregnant or breastfeeding

Trial design

This trial will recruit 450 people from around the world.

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

People in group A have eribulin. You have eribulin through a drip into a vein on the first and 8th day of every 3 week period.

People in group B have dacarbazine through a drip into a vein once every 3 weeks.

Each 3 week period is called a cycle of treatment. You have treatment for as long as it is helping you.

You fill out a questionnaire before you start treatment, on the first day of each treatment cycle, at the end of treatment then every 6 weeks after that. The questionnaire will ask 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 for a sample of tissue taken when you had surgery to diagnose your cancer. They will also ask for extra blood samples for research. If you do not want to give extra blood samples for research, you don’t have 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 include

You see the doctors and have regular blood tests while you are having treatment. You have a CT or MRI scan every 6 weeks for 12 weeks then every 9 weeks until your cancer starts to grow again. You have a bone scan every 6 months.

When you stop treatment you see the doctors again for an ECG, physical examination, blood and urine tests. Depending on which you prefer, the doctors will either see you at the hospital or ring you at home every 3 months, to see how you are.

Side effects

The most common side effects of eribulin are

The most common side effects of dacarbazine are

We have more information about the side effects of eribulin and dacarbazine in our cancer drugs section.

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 Michael Leahy

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9350

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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