ISRCTN16387614已完成3 期
Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma
Cancer Research UK (CRUK) (UK)0 个研究点目标入组 214 人开始时间: 2001年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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