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

Phase 2

• Conditions: Renal Cell Carcinoma; Pulmonary Metastases
• Interventions: Drug: Placebo; Drug: Sunitinib

• Registration Number: NCT01216371
• Lead Sponsor: Association of Urologic Oncology (AUO)

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 year

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	one year treatment with placebo
Sunitinib	Sunitinib	one year adjuvant treatment with sunitinib

Primary Outcome Measures

Name	Time	Method
2 year relapse-free survival	5 years

Secondary Outcome Measures

Name	Time	Method
Side effect of adjuvant therapy	5 years
Quality of Life of the Patient	5 years
Overall Survival	5 years
perioperative mortality and morbidity	5 years

Trial Locations

Locations (11)

university hospital of Freiburg; 🇩🇪 Freiburg, Germany

Universitätsmedizin Charité Berlin; 🇩🇪 Berlin, Germany

university hospital of Essen; 🇩🇪 Essen, Germany

university Hospital of Heidelberg; 🇩🇪 Heidelberg, Germany

urological hospital of Maria Hilf Krankenhaus Krefeld; 🇩🇪 Krefeld, Germany

Hospital of Großhadern; 🇩🇪 München, Germany

Franziskus Krankenhaus; 🇩🇪 Berlin, Germany

university hospital of Düsseldorf; 🇩🇪 Düsseldorf, Germany

Helios Klinikum Emil von Behring; 🇩🇪 Berlin, Germany

Ruhrlandklinik Department of Thoracic Surgery; 🇩🇪 Essen, Germany

Dr.-Horst-Schmidt-Kliniken GmbH; 🇩🇪 Wiesbaden, Germany