EUCTR2008-007609-36-DE进行中（未招募）不适用
Prospektiv randomisierte multizentrische Phase II-Studie zur Metastasenresektion von Lungenfiliae (poor-prognosis) beim klarzelligen Nierenzellkarzinom +/- adjuvante Sunitinibtherapie über 1 Jahr - SMAT - SMAT
niversity of Essen0 个研究点目标入组 60 人开始时间: 2010年5月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age between 18 and 75 years
- •Functional justifyable risko of operation
- •Women in childbearing age: negative test on pregnancy and adequate contraception
- •Satisfying hematologic, renal, hepatic and coagulation functions
- •Amylase / Lipase < 1,5 x upper limit of normal range
- •Information of patient on study andwritten informed consent per German laws
- •Patient is compliant and living nearby to grant an adequate follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Finding of other metastases outside the lung
- •Progress under 12-week Sunitinib-therapy prior to metastasesresection
- •R1 or R2-outcome of metastasesresection
- •Need of dialysis after nephrektomy
- •prior or active severe cardiovascular (Grade III - IV per NYHA) disease(Heartinfarction within last 6 months , hardly controlled hypertension (RR diastolic >= 120 mmHg))
- •Severe hematopoetic (z.B. severe bone marrow aplasia), pulmonal, hepatic or renal diseases
- •Apoplex within last 6 Months
- •Patients with hardly controlled diabetes mellitus
- •Severe bacterial or fungal infections
- •Chronic Hepatitis B or C ; HIV-Infection
- •Autoimmune disease
- •Prior organ transplantation
- •Prior autolog bone marrow transplantation or applicaton of stem cells within 4 months prior to study start
- •Neuropsychiatric diseases, which influence compliance ofPatient
- •Manifest second malignom or other cancer disease within last 5 years (except basaliom, Carcinoma in situ of cervix, incidential prostate cancer, superficial urothel cancer)
- •Therapy with immuntherapeutics including monoklonal antibody, cytostatics or hormons (except bisphosphonat and anticonceptivs) innerwithin last 4 weeks prior to study start. Prior use of inhibitors of Ras/Raf-, MEK-, AKT kinase- and mTOR-Signalinduction or of inhibitors of farnesyltransferase
- •Prior use of angiogenese-inhibitors like VEGF/VEGFR, PDGF/PDGFR or other key molecules of angiogenese
- •Parallel application of Rifampicin
- •Participation in other therapy-studies within last 4 weeks
研究者
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