Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma
- Conditions
- CancerKidneyCancer, kidney
- Registration Number
- ISRCTN16387614
- Lead Sponsor
- Cancer Research UK (CRUK) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 214
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival or overall survival
- Secondary Outcome Measures
Name Time Method Quality of life