A randomised controlled trial of Interferon-a, Interleukin-2 and 5-Fluorouracil vs Interferon-a alone in patients with advanced renal cell carcinoma

Testing two different chemotherapy treatments for people with advanced kidney cancer

What is this study about?

Kidney or renal cell cancer (RCC) is the 13th commonest cancer diagnosed in the UK. Around 6,200 people are diagnosed with this type of cancer every year, and this figure is rising. Sadly about one third of these people will die from the cancer. Nearly 2 out of every 3 people who are diagnosed with kidney cancer (62%) are over 65 years old. Kidney cancer is more common in men than in women. Around one quarter of people diagnosed with kidney cancer will have metastatic disease (this means that the cancer has spread to other parts of their body).

Doctors usually treat people with metastatic kidney cancer with a drug called interferon-a (IFN-a). They offer this drug to people who are well enough to cope with this treatment. More recently, some doctors have used a combination of drugs to treat people with this type of cancer. The RE04 trial aims to test how well three drugs (interferon –a, along with two drugs called IL-2 and 5FU) work in comparison to interferon-a alone. RE04 is an open-label randomised controlled phase III trial.

The trial is looking at:

  1. Whether the combination of drugs will help people to live for longer than the single drug
  2. Whether the combination of drugs cause more (or less) unwanted side effects than the single drug
  3. The quality of life of people taking the single drug and the combination of drugs
  4. The health economics of using the three drugs in comparson to one drug

Type of study

Randomised trial

Contact details

Who is funding the study?

This trial is being funded by the Medical Research Council.

When is it taking place?

The trial opened to recruitment in April 2001. The trial closed to recruitment in July 2006.

Where is it taking place?

The trial is an international study being conducted at various hospitals in the UK and in other European countries.

Who is included?

Patients who have advanced kidney cancer.