Status:
UNKNOWN
Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)
Lead Sponsor:
Association of Urologic Oncology (AUO)
Collaborating Sponsors:
University Hospital, Essen
Conditions:
Renal Cell Carcinoma
Pulmonary Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.
Detailed Description
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 y...
Eligibility Criteria
Inclusion
- \>/= 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01216371
Start Date
October 1 2010
End Date
October 1 2015
Last Update
February 13 2012
Active Locations (11)
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1
Universitätsmedizin Charité Berlin
Berlin, Germany, 10117
2
Franziskus Krankenhaus
Berlin, Germany, 10787
3
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
4
university hospital of Düsseldorf
Düsseldorf, Germany, 40255