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

February 10, 2012 updated by: Heidrun Rexer, Association of Urologic Oncology (AUO)

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Susanne Krege, Priv. Doz. Dr. med.
  • Phone Number: 02 151 / 334-23 81

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Universitätsmedizin Charité Berlin
        • Contact:
          • Steffen Weikert, Priv. Doz. Dr. med.
          • Phone Number: 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
      • Berlin, Germany, 10787
        • Not yet recruiting
        • Franziskus Krankenhaus
        • Contact:
          • Jörg Neymeyer, Dr. med.
          • Phone Number: 030/26 38-38 01
        • Principal Investigator:
          • Jörg Neymeyer, Dr. med.
        • Sub-Investigator:
          • Thomas Wülfing, Dr. med.
      • Berlin, Germany, 14165
        • Not yet recruiting
        • Helios Klinikum Emil Von Behring
        • Contact:
          • Kollmeier Jens, Dr. med.
          • Phone Number: 030/81 02-14 47
        • Sub-Investigator:
          • Jens Kollmeier, Dr. med.
        • Sub-Investigator:
          • Bettina Schlolaut, Dr. med.
      • Düsseldorf, Germany, 40255
        • Recruiting
        • University Hospital of Düsseldorf
        • Contact:
          • Peter Albers, Prof. Dr. med.
          • Phone Number: 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
      • Essen, Germany, 45122
        • Recruiting
        • University Hospital of Essen
        • Contact:
          • Herbert Rübben, Prof. Dr. med.
          • Phone Number: 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
      • Essen, Germany, 45239
        • Not yet recruiting
        • Ruhrlandklinik Department of Thoracic Surgery
        • Contact:
          • Christiane Zimmermann
          • Phone Number: 0201/433-43 24
        • Sub-Investigator:
          • Georgios Stamatis, Prof. Dr. med.
        • Sub-Investigator:
          • Stefan Welter, Dr. med.
        • Sub-Investigator:
          • Silvia Fechner, Dipl. med.
      • Freiburg, Germany, 79106
        • Recruiting
        • University Hospital of Freiburg
        • Contact:
          • Ulrich Wetterauer, Prof. Dr. med.
          • Phone Number: 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.
      • Heidelberg, Germany, 69119
        • Recruiting
        • University Hospital of Heidelberg
        • Contact:
          • Markus Hohenfellner, Prof. Dr. med.
          • Phone Number: 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.
      • Krefeld, Germany, 47805
        • Recruiting
        • urological hospital of Maria Hilf Krankenhaus Krefeld
        • Contact:
          • Susanne Krege, Priv. Doz. Dr. med.
          • Phone Number: 02151/334-52 74
        • Principal Investigator:
          • Susanne Krege, Priv. Doz. Dr. med.
        • Sub-Investigator:
          • Florian Hartmann, Dr. med.
      • München, Germany, 81377
        • Not yet recruiting
        • Hospital of Großhadern
        • Contact:
          • Michael Staehler, Dr. med.
          • Phone Number: 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
      • Wiesbaden, Germany, 65199
        • Recruiting
        • Dr.-Horst-Schmidt-Kliniken GmbH
        • Contact:
          • Norbert Frickhofen, Prof. Dr. med.
          • Phone Number: 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Plazebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Urologic Oncology (AUO)

Collaborators

University Hospital, Essen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

February 13, 2012

Last Update Submitted That Met QC Criteria

February 10, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN 20/04
  • 2008-007609-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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