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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Association of Urogenital Oncology (AUO)
Sponsor:
Collaborator:
University Hospital, Essen
Information provided by (Responsible Party):
Heidrun Rexer, Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier:
NCT01216371
First received: October 6, 2010
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Renal Cell Carcinoma
Pulmonary Metastases
 Drug: Sunitinib
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association of Urogenital Oncology (AUO):

Primary Outcome Measures:
  • 2 year relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • perioperative mortality and morbidity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Side effect of adjuvant therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of Life of the Patient [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216371

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         
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.         
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.         
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 Urogenital Oncology (AUO)
University Hospital, Essen
Investigators
Principal Investigator: Susanne Krege, Priv. Doz. Dr. med. urological hospital of Maria Hilf Krankenhaus Krefeld
  More Information

No publications provided

Responsible Party: Heidrun Rexer, Priv. Doz. Dr. med. Susanne Krege, urological hospital of Maria Hilf Krankenhaus Krefeld, Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01216371     History of Changes
Other Study ID Numbers: AN 20/04, 2008-007609-36
Study First Received: October 6, 2010
Last Updated: February 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Association of Urogenital Oncology (AUO):
carcinoma
metastases
renal
lung

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Lung Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015