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临床试验/NL-OMON30718
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

发起方
Antoni van Leeuwenhoek Ziekenhuis

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