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

Cancer type:

Soft tissue sarcoma




Phase 3

This trial compared a combination of doxorubicin and ifosfamide with doxorubicin alone for advanced sarcoma.

Doctors usually treat soft tissue sarcoma with surgery and radiotherapy. Sometimes sarcoma spreads to another part of the body or comes back (recurs) after treatment. This is called advanced or metastatic cancer.

Then doctors may use chemotherapy drugs to treat advanced soft tissue sarcoma. Two of the drugs they use are ifosfamide and doxorubicin (Adriamycin). Some doctors thought that having 2 chemotherapy drugs together may be better at controlling advanced soft tissue sarcoma than one drug on its own. But it wasn’t clear, and giving 2 drugs instead of 1 was likely to cause more side effects.

The aim of this trial was to see if doxorubicin and ifosfamide together was better at treating advanced sarcoma than doxorubicin on its own.

Summary of results

The trial team found that ifosfamide and doxorubicin was no better than doxorubicin on its own for treating advanced sarcoma.

This was an international phase 3 trial. It was a randomised trial. The 455 people recruited were put into 1 of 2 treatment groups

  • 227 had doxorubicin and ifosfamide
  • 228 had doxorubicin

The average follow up was just over 4½ years. After the 1st year, 60 out of every 100 people (60%) who had doxorubicin and ifosfamide were alive and 51 out of every 100 people (51%) who had doxorubicin were. The researchers say that the difference between the 2 groups could have happened by chance. So the result was not a statistically significant Open a glossary item one.

After the 2nd year, the researchers found no difference between the 2 groups in the number of people who were still alive.

The amount of time it took before their cancer started to grow again was

  • Just over 7½ months for those who had doxorubicin and ifosfamide
  • Just over 4½ months for those who had doxorubicin

A drop in blood cells was a more common side effect for those who had doxorubicin and ifosfamide.

The trial team concluded that for as far as the length of time people lived doxorubicin and ifosfamide was not better than doxorubicin only to treat advanced sarcoma. They say in situations where the doctor wants to shrink the tumour doxorubicin and ifosfamide may be better than doxorubicin only. Apart from this doxorubicin alone remains the standard treatment for advanced sarcoma.

We have based this summary on information from the team who ran the trial. 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. 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

Professor Ian Judson

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)

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Last review date

CRUK internal database number:

Oracle 256

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

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"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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