Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)

Study Overview
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Brief Summary
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The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.

Detailed Description
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Prospective randomized multi-center Phase II trial for resection of metastases from pulmonary metastases (poor prognosis) in clear cell renal cell carcinoma + / - adjuvant sunitinib therapy over one year

Official Title
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Prospektiv Randomisierte Multizentrische Phase II-Studie Zur Metastasenresektion Von Lungenfiliae (Poor-prognosis) Beim Klarzelligen Nierenzellkarzinom +/- Adjuvante Sunitinibtherapie über 1 Jahr SMAT - AN 20/04 Der AUO

Conditions
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Renal Cell Carcinoma, Pulmonary Metastases

Intervention / Treatment
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* Drug: Sunitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 2 synchronous or within 24 Months after Nephrectomy occured pulmonary metastases. Patients in whom more back than 2 years of a solitary lung metastasis, bone metastasis or brain metastasis was resected, may also be included in the study. Aged 18 to 75 years functionally acceptable surgical risk Women in conceptional age: negative pregnancy test and adequate contraception Adequate hematologic, renal, hepatic and coagulation-physiological functions Amylase/ Lipase < 1,5 x upper limit of normal Informing the patient about the study and the present written consent to participate after clarification in accordance with the stipulations of AMG(german drug law), and the principles of GCP (informed consent) Patient compliance and geographic proximity to allow adequate follow-up Exclusion Criteria: Presence of other metastases outside the lung progress in the 12-week sunitinib therapy before resection of metastases R1 or R2-finding in resection of metastases Dialysis after nephrectomy Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction within previous 6 months , uncontrolled hypertension(RR diastolic 120 mmHg(Millimeters of mercury)) serious hematopoetic (e.g. serious Bone marrow aplasia), pulmonary, hepatic or renal Disease Stroke within the previous six months Patients with poorly controlled diabetes mellitus Serious bacterial or fungal infections chronic hepatitis B or C, HIV(human immunodeficiency virus) infection autoimmune disease prior organ transplantation prior autologous bone marrow transplant or stem cell transferred within the last 4 months before study Neuropsychiatric diseases that affect patient compliance Manifesto, second malignancy or other malignancy within the past 5 years (except basal cell carcinoma, carcinoma in situ of the cervix, incidental prostate carcinoma, superficial urothelial Ca pTaG1-2 and pT1G1) Therapy with immunotherapeutic agents including monoclonal antibodies, cytotoxic drugs or hormones (other than bisphosphonates and oral contraceptives) within the last 4 weeks prior to enrollment. Previous use of inhibitors of Ras/Raf-, MEK kinase, AKT kinase and mTOR inhibitors or induction of Farnesyltransferase Previous use of angiogenesis inhibitors such as VEGF / VEGFR, PDGF / PDGFR and other key molecules of angiogenesis parallel treatment with rifampicin Participation in other treatment studies in the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sunitinib<br>one year adjuvant treatment with sunitinib | Drug: Sunitinib<br>* one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break<br>* Other names: adjuvant Treatment;|
| Placebo Comparator: Placebo<br>one year treatment with placebo | Drug: Placebo<br>* one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break,<br>* Other names: Plazebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 year relapse-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative mortality and morbidity |  | 5 years | 
| Side effect of adjuvant therapy |  | 5 years | 
| Quality of Life of the Patient |  | 5 years | 
| Overall Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carcinoma, metastases, renal, lung