A trial comparing two treatment plans for advanced kidney cancer (RE04)

Cancer type:

Kidney cancer
Renal cell carcinoma

Status:

Results

Phase:

Phase 3

This trial looked at adding the drugs fluorouracil and interleukin 2 to interferon to see if this treatment worked better than interferon alone.

Doctors treat early stage renal cell cancer (the most common form of kidney cancer) with surgery. Sometimes the cancer comes back, or spreads to other parts of the body and becomes advanced cancer. If this happens, doctors used to use a type of biological therapy called interferon. But now they often use other treatments that have been shown to work better.

When this trial started, doctors had hoped that adding another biological therapy called interleukin and a chemotherapy drug called fluorouracil (5FU) may work better than interferon alone.

The aim of this trial was to compare interferon alone with the combination of interferon, interleukin and 5FU to find out

  • Which treatment worked best for advanced kidney
  • More about the side effects

Summary of results

The research team found that the combination of interferon, interleukin and 5FU did not work better than interferon alone.

This was a randomised trial and it recruited 1,006 patients from around the world, including the UK. Of these

  • 504 had interferon, interleukin and 5FU
  • 502 had interferon alone

The research team looked at results in September 2008 to see how well the treatment had worked.

They found that of the 502 people who had interferon alone

  • In 38 people, there was no sign that the cancer had continued to grow
  • In 124 people, the cancer had continued to grow
  • 340 people had died

Of the 504 people who had the combination treatment

  • In 47 people, there was no sign that their cancer had continued to grow
  • In 106 people, the cancer had continued to grow
  • 351 people had died

They found that 67 out of 100 people (67%) in each group lived for at least 1 year after they joined the trial. And that 30% of people who had interferon alone lived for at least 3 years, compared with 26% of those who had the new combination.

The side effects were similar in each group, although more people in the combination group had severe side effects.

The research team concluded that there was no benefit of adding interleukin and 5FU to interferon. The cancer stopped growing or grew more slowly for a time in more people who had the combination treatment. But this didn’t affect how long people lived for.

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) 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

Prof Martin Gore

Supported by

Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 64

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

A picture of Wendy

"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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