Kidney cancer with lung metastases MedDRA version: 12.1 Level: LLT Classification code 10023400 Term: Kidney cancer MedDRA version: 12.1 Level: LLT Classification code 10025111 Term: Lung metastases
Conditions
Interventions
Trade Name: Sutent 12,5 mg Hartkapseln
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Other descriptive name: SUNITINIB MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
University of Essen
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Recidive-free survival within 2 years;Secondary Objective: Peripoperativ mortality and morbidity, Adverse Events of adjuvant therapy, overall survival, quality of life;Primary end point(s): Recidive-free survival within 2 years | — |
Countries
Germany
Outcome results
None listed