Prospektiv randomisierte multizentrische Phase II-Studie zur Metastasenresektion von Lungenfiliae (poor-prognosis) beim klarzelligen Nierenzellkarzinom +/- adjuvante Sunitinibtherapie über 1 Jahr - SMAT - SMAT

• Conditions: Kidney cancer with lung metastases; MedDRA version: 12.1Level: LLTClassification code 10025111Term: Lung metastases; MedDRA version: 12.1Level: LLTClassification code 10023400Term: Kidney cancer

• Registration Number: EUCTR2008-007609-36-DE
• Lead Sponsor: niversity of Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-10
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified