Renal Cancer Cancer Renal cell carcinoma
Conditions
Interventions
Arm 1: IFN-alpha until progression
Arm 2: IFN-alpha, IL-2 and 5-FU (max 2 cycles)
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven renal cell carcinoma. Material may be obtained from the primary tumour or the metastases 2. Advanced metastatic disease ? that, in the opinion of the investigator, requires treatment. (We would recommend that patients have undergone resection of their primary tumour prior to entry into the trial but this is not mandatory) 3. 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) 4. WHO performance status 0 or 1 5. Normal haematological parameters (WBC >3 x 109/l; platelets >100 x 109/l; haemoglobin >10g/dl). This assessment should be carried out within 7 days before randomisation 6. Creatinine levels must be within normal limits for institution. If creatinine raised, then EDTA or creatinine clearance should be greater than 60ml/min 7. Life expectancy greater than 12 weeks 8. Written informed consent 9. Male or female patient of any ethnic group more than 18 years in age
Exclusion criteria
Exclusion criteria: 1. No radiotherapy to target lesions during trial therapy 2. Previous chemotherapy, endocrine therapy or treatment with biological agents 3. No current or previous brain metastasis 4. Unstable angina pectoris or recent (6 month) myocardial infarction 5. Evidence of active infections requiring antibiotic therapy 6. 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-alpha 7. Patients who require or are likely to require corticosteroids for intercurrent disease 8. Pregnant or lactating women 9. Other disease or previous malignancy likely to interfere with the protocol treatments or comparisons 10. Patients with concurrent malignancy, unless they have remained free of the disease attributed to the malignancy for more than 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is survival. The primary endpoint, which will be used to evaluate the efficacy of the treatment regimens, will be time to death. All deaths should be reported immediately and time to death will be calculated from the date of randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to disease progression. Progression is defined according to the RECIST guidelines 2. Comparison of toxicity levels, principally grade III/IV 3. Quality of life will be assessed before, during and after treatment 4. The impact of the treatment regimens on health economics will also be evaluated | — |
Countries
Belgium, Denmark, Germany, Netherlands, Slovakia, United Kingdom
Outcome results
None listed