Cancer, kidney Cancer Kidney
Conditions
Interventions
This is a randomised, multicenter study. Patients are randomised to one of two treatment arms:
Arm 1: Patients receive interleukin-2 subcutaneously (SC) on days three, four, and five of weeks one and
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Surgical resection of primary renal cell carcinoma. A lymph node dissection to differentiate between N+ and N- is optional. Removal of clinical N+ disease is obligatory 2. No metastatic or macroscopic residual disease 3. Patients should have: 1.1. Histologically proven T3b, T3c or T4 tumour or Any pT stage and nodal status pN1/2 or 1.2. Any pT stage and microscopic positive margins or 1.3. Presence of any microscopic vascular invasion 4. World Health Organisation (WHO) performance status zero or one 5. Aged 75 years or less 6. White Blood Cells (WBC) more than or equal to 3.5 x 10^9/l, platelets more than or equal to 100 x 10^9/l 7. Liver Function Tests (LFTs) less than or equal to 1.25 x Upper Limit of Normal (ULN), serum creatinine less than 1.5 x ULN 8. Randomisation to be carried out as close as possible to the time at which adjuvant surgery would begin, but no later than 12 weeks following surgery 9. Informed consent of the patient
Exclusion criteria
Exclusion criteria: 1. Unstable angina or Myocardial Infarction (MI) 2. Active infection requiring antibiotic 3. Major organ allograft 4. Patients likely to require corticosteroids for intercurrent disease 5. Pregnant/lactating women 6. Patients with concomitant or previous malignancies 7. Patients who have received radiation or chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival or overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | — |
Countries
United Kingdom
Outcome results
None listed