Cancer Cancer Renal carcinoma
Conditions
Interventions
1. One group receives recombinant alpha-interferon
2. The other group receives medroxyprogesterone
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven renal cell carcinoma with evaluable metastatic disease 2. World Health Organisation (WHO) performance status 0-2 3. No previous malignancy (except non-melanotic skin cancer or in situ carcinoma of the cervix) 4. Three groups of patients are eligible: (a) Those patients who have had a nephrectomy in the past and develop metastatic disease during follow up. Patients can be randomised when metastatic disease has been confirmed and the patient fits the other eligibility criteria. (b) Those patients who present with metastatic disease and have had the primary tumour removed within the last 4 weeks. Patients should be randomised once the nephrectomy has been performed and the wound has healed. (c) Those patients who present with metastatic disease where nephrectomy is not planned. Patients can be randomised at presentation.
Exclusion criteria
Exclusion criteria: Patients with cardiac disease which may preclude alpha-interferon or those with known brain metastases must be excluded. No previous RT, hormonal, cytotoxic or immuno-therapy within 12 weeks of the proposed date of randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Survival time 2. Response rate 3. Time to progression 4. Quality of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed