NL-OMON30718尚未招募不适用
Feasibility of lymphoscintigraphy and sentinel node biopsy in patients with renal cell carcinoma - Sentinel node procedure in kidney cancer
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Localized parenchymal tumor of the kidney not exceeding 10 cm (cT1-cT2)
- •2. No metastatic disease on imaging and clinical examination (cN0, cM0)
- •3. Age: 18 to 65 years
- •4. Life expectancy > 3 months
- •5. WHO performance status 0 or 1 and fit for surgery
- •6. Written informed consent obtained from the patient after having been informed about the objectives of the study and the medication used.
- •7. Blood counts: Leucocytes > 3.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 6.0 mmol/l.
- •8. Serum bilirubin, ASAT, ALAT and creatinin within 1.5 times of upper limit of reference values of laboratory.
- •9. No prior systemic treatment with biological response modifiers, tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy.
排除标准
- •1. Parenchymal kidney tumor larger than 10 cm
- •2. clinically metastatic disease or at imaging
- •3. Patients in whom surgery is no option due to comorbidity
- •4. Current cardiovascular disease, hematopoetic, pulmonary, hepatic or renal dysfunction or WHO performance status > 1.
- •5. Previous immunotherapy, therapy with tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy.
- •6. Corticosteroid and/ or other immunosuppressive therapies.
- •7. Prior malignancies. In case of NED the period should be > 5 years.
- •8. Pregnancy
研究者
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