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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Renal Cell Carcinoma; Pulmonary Metastases	Drug: Sunitinib; Drug: Placebo	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	October 2010
Estimated Primary Completion Date :	October 2015
Estimated Study Completion Date :	October 2015

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Sunitinib; one year adjuvant treatment with sunitinib	Drug: Sunitinib; one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break; Other Name: adjuvant Treatment
Placebo Comparator: Placebo; one year treatment with placebo	Drug: Placebo; one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break,; Other Name: Plazebo

Outcome Measures

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Primary Outcome Measures :

1. 2 year relapse-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. perioperative mortality and morbidity [ Time Frame: 5 years ]
2. Side effect of adjuvant therapy [ Time Frame: 5 years ]
3. Quality of Life of the Patient [ Time Frame: 5 years ]
4. Overall Survival [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Contacts

Contact: Susanne Krege, Priv. Doz. Dr. med.	02 151 / 334-23 81

Locations

Germany
Universitätsmedizin Charité Berlin	Not yet recruiting
Berlin, Germany, 10117
Contact: Steffen Weikert, Priv. Doz. Dr. med. 030/84 45-40 84
Principal Investigator: Steffen Weikert, Priv. Doz. Dr. med.
Sub-Investigator: Kempkensteffen Carsten, Dr. med.
Sub-Investigator: Jonas Busch, Dr. med.
Sub-Investigator: Jan Gregor, Dr. med.
Sub-Investigator: Jens Neudecker, Dr. med.
Sub-Investigator: Jens C. Rückert, Dr. med.
Sub-Investigator: Gertrud Feldmann
Franziskus Krankenhaus	Not yet recruiting
Berlin, Germany, 10787
Contact: Jörg Neymeyer, Dr. med. 030/26 38-38 01
Principal Investigator: Jörg Neymeyer, Dr. med.
Sub-Investigator: Thomas Wülfing, Dr. med.
Helios Klinikum Emil von Behring	Not yet recruiting
Berlin, Germany, 14165
Contact: Kollmeier Jens, Dr. med. 030/81 02-14 47
Sub-Investigator: Jens Kollmeier, Dr. med.
Sub-Investigator: Bettina Schlolaut, Dr. med.
university hospital of Düsseldorf	Recruiting
Düsseldorf, Germany, 40255
Contact: Peter Albers, Prof. Dr. med. 0211/811-81 10
Principal Investigator: Peter Albers, Prof. Dr. med.
Sub-Investigator: Jasper Decoene
Sub-Investigator: Zenginli Hakan
Sub-Investigator: Claus F. Eisenberger, Prof. Dr. med.
Sub-Investigator: Wolfram T. Knoefel, Prof. Dr. med.
Sub-Investigator: Almut Diem
university hospital of Essen	Recruiting
Essen, Germany, 45122
Contact: Herbert Rübben, Prof. Dr. med. 0201/723-32 10
Principal Investigator: Herbert Rübben, Prof. Dr. med.
Sub-Investigator: Marcus Schenk, Dr. med.
Sub-Investigator: Farnk vom Dorp, Dr. med.
Sub-Investigator: Min Ju, Dr. med.
Sub-Investigator: Stephan Tschirdewahn
Sub-Investigator: Michaela Löbert
Ruhrlandklinik Department of Thoracic Surgery	Not yet recruiting
Essen, Germany, 45239
Contact: Christiane Zimmermann 0201/433-43 24
Sub-Investigator: Georgios Stamatis, Prof. Dr. med.
Sub-Investigator: Stefan Welter, Dr. med.
Sub-Investigator: Silvia Fechner, Dipl. med.
university hospital of Freiburg	Recruiting
Freiburg, Germany, 79106
Contact: Ulrich Wetterauer, Prof. Dr. med. 0761/270-2891
Principal Investigator: Ulrich Wetterauer, Prof. Dr. med.
Sub-Investigator: Christian Leiber, Dr. med.
Sub-Investigator: Christian Stremmel, Prof. Dr. med.
Sub-Investigator: Jutta Günter, Dr. med.
university Hospital of Heidelberg	Recruiting
Heidelberg, Germany, 69119
Contact: Markus Hohenfellner, Prof. Dr. med. 06221/56-63 21
Principal Investigator: Markus Hohenfellner, Prof. Dr. med.
Sub-Investigator: Pahernick Sascha, Priv. Doz. Dr. med.
Sub-Investigator: Gencay Hatiboglu, Dr. med.
Sub-Investigator: Johannes Huber, Dr. Dr. med.
Sub-Investigator: Joachim Pfannschmidt, Priv. Doz. Dr. med.
Sub-Investigator: Hendrik Dienemann, Prof. Dr. med.
urological hospital of Maria Hilf Krankenhaus Krefeld	Recruiting
Krefeld, Germany, 47805
Contact: Susanne Krege, Priv. Doz. Dr. med. 02151/334-52 74
Principal Investigator: Susanne Krege, Priv. Doz. Dr. med.
Sub-Investigator: Florian Hartmann, Dr. med.
Hospital of Großhadern	Not yet recruiting
München, Germany, 81377
Contact: Michael Staehler, Dr. med. 089/70 95-0
Principal Investigator: Michael Staehler, Dr. med.
Sub-Investigator: Cordula Nordhaus, Dr. med.
Sub-Investigator: Philipp Nuhn, Dr. med.
Sub-Investigator: Hauke Winter, Priv. Doz. Dr. med.
Sub-Investigator: Rudolf Hatz, Prof. Dr. med.
Sub-Investigator: Sylvia Dondl
Dr.-Horst-Schmidt-Kliniken GmbH	Recruiting
Wiesbaden, Germany, 65199
Contact: Norbert Frickhofen, Prof. Dr. med. 0611/43-30 09
Principal Investigator: Norbert Frickhofen, Prof. Dr. med.
Sub-Investigator: Bernd Jung, Dr. med.
Sub-Investigator: Heinz G. Fuhr, Dr. med.
Sub-Investigator: Joachim Schirren, Prof. Dr. med.
Sub-Investigator: Servet Bölükbas, Dr. med.
Sub-Investigator: Sabine Labenz
Sub-Investigator: Birgit Wilde
Sub-Investigator: Klaudia Fischbach

Sponsors and Collaborators

Association of Urologic Oncology (AUO)

University Hospital, Essen

Investigators

Principal Investigator:	Susanne Krege, Priv. Doz. Dr. med.	urological hospital of Maria Hilf Krankenhaus Krefeld

More Information

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Responsible Party:	Heidrun Rexer, Priv. Doz. Dr. med. Susanne Krege, urological hospital of Maria Hilf Krankenhaus Krefeld, Association of Urologic Oncology (AUO)
ClinicalTrials.gov Identifier:	NCT01216371 History of Changes
Other Study ID Numbers:	AN 20/04; 2008-007609-36 ( EudraCT Number )
First Posted:	October 7, 2010
Last Update Posted:	February 13, 2012
Last Verified:	February 2012

Keywords provided by Heidrun Rexer, Association of Urologic Oncology (AUO):

carcinoma; metastases; renal; lung

Additional relevant MeSH terms:

Carcinoma; Neoplasm Metastasis; Carcinoma, Renal Cell; Lung Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site	Kidney Diseases; Urologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Sunitinib; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors