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RE04: 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
  • Who is included?

    Patients who have advanced kidney cancer
  • 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 funding the study?

    This trial is being funded by the Medical Research Council
  • Contact details

  • Further Information

    Type of study:Randomised trial
    Study start date:24-Apr-2001
    Study end date:31/07/2006 (Recruitment of last patient)
    Randomisation target:1100
    Randomisations achieved:1006, as of 31/07/2006
    Also included in this study:Health Economics
    Quality of life outcomes
    Chief investigator:Professor Martin Gore
    Sponsor:Medical Research Council
    Registration numbers:Eudract Number: 2005-004819-30
    ISRCTN Number: 46518965
    CTA Number: 00316/0022/001
    Inclusion criteria:
    • Histologically proven renal cell carcinoma. Material may be obtained from the primary tumour or the metastases.
    • Advanced metastatic disease – that, in the opinion of the investigator, requires treatment*.
    • At least one measurable lesion. Measurements must be taken within the 4 week period before the start of treatment (single bone lesions should not be included due to assessing response).
    • WHO performance status 0 or 1.
    • Normal haematological parameters (WBC > 3x109/l; platelets > 100x109/l; Haemoglobin > 10g/dl). This assessment should be carried out within 7 days before randomisation.
    • Creatinine levels must be within normal limits for institution. If creatinine raised, then EDTA or creatinine clearance should be greater than 60mls/min.
    • Life expectancy greater than 12 weeks.
    • Written informed consent.
    • Male or female patient of any ethnic group more than 18 years in age.
    * NB. We would recommend that patients have undergone resection of their primary tumour prior to entry into the trial but this is not mandatory.
    Exclusion criteria:
    • No radiotherapy to target lesions during trial therapy.
    • Previous chemotherapy, endocrine therapy or treatment with biological agents.
    • No current or previous brain metastasis.
    • Unstable angina pectoris or recent (6 months) myocardial infarction.
    • Evidence of active infections requiring antibiotic therapy.
    • Patients with major organ allografts (IL-2 may increase T-cell mediated rejection and immunosuppressive agents are likely to reduce efficacy of IL-2 and IFN-?).
    • Patients who require or are likely to require corticosteroids for intercurrent disease.
    • Pregnant or lactating women.
    • Other disease or previous malignancy likely to interfere with the protocol treatments or comparisons.
    • Patients with concurrent malignancy, unless they have remained free of the disease attributed to the malignancy for more than 5 years.
    Intervention and control groups:Immunotherapy
    Method of randomisation:Based on stratification factors