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

Primary Purpose

Renal Cell Carcinoma, Pulmonary Metastases

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Sunitinib

Placebo

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring carcinoma, metastases, renal, lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitätsmedizin Charité Berlin
Franziskus Krankenhaus
Helios Klinikum Emil von Behring
university hospital of DüsseldorfRecruiting
university hospital of EssenRecruiting
Ruhrlandklinik Department of Thoracic Surgery
university hospital of FreiburgRecruiting
university Hospital of HeidelbergRecruiting
urological hospital of Maria Hilf Krankenhaus KrefeldRecruiting
Hospital of Großhadern
Dr.-Horst-Schmidt-Kliniken GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sunitinib

Placebo

Arm Description

one year adjuvant treatment with sunitinib

one year treatment with placebo

Outcomes

Primary Outcome Measures

2 year relapse-free survival

Secondary Outcome Measures

perioperative mortality and morbidity

Side effect of adjuvant therapy

Quality of Life of the Patient

Overall Survival

Full Information

NCT ID

NCT01216371

First Posted

October 6, 2010

Last Updated

February 10, 2012

Sponsor

Association of Urologic Oncology (AUO)

Collaborators

University Hospital, Essen

1. Study Identification

Unique Protocol Identification Number

NCT01216371

Brief Title

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

Acronym

SMAT

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 Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Association of Urologic Oncology (AUO)

Collaborators

University Hospital, Essen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma, Pulmonary Metastases

Keywords

carcinoma, metastases, renal, lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib

Arm Type

Active Comparator

Arm Description

one year adjuvant treatment with sunitinib

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

one year treatment with placebo

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

adjuvant Treatment

Intervention Description

one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Plazebo

Intervention Description

one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break,

Primary Outcome Measure Information:

Title

2 year relapse-free survival

Time Frame

5 years

Secondary Outcome Measure Information:

Title

perioperative mortality and morbidity

Time Frame

5 years

Title

Side effect of adjuvant therapy

Time Frame

5 years

Title

Quality of Life of the Patient

Time Frame

5 years

Title

Overall Survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susanne Krege, Priv. Doz. Dr. med.

Phone

02 151 / 334-23 81

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne Krege, Priv. Doz. Dr. med.

Organizational Affiliation

urological hospital of Maria Hilf Krankenhaus Krefeld

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsmedizin Charité Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steffen Weikert, Priv. Doz. Dr. med.

Phone

030/84 45-40 84

First Name & Middle Initial & Last Name & Degree

Steffen Weikert, Priv. Doz. Dr. med.

First Name & Middle Initial & Last Name & Degree

Kempkensteffen Carsten, Dr. med.

First Name & Middle Initial & Last Name & Degree

Jonas Busch, Dr. med.

First Name & Middle Initial & Last Name & Degree

Jan Gregor, Dr. med.

First Name & Middle Initial & Last Name & Degree

Jens Neudecker, Dr. med.

First Name & Middle Initial & Last Name & Degree

Jens C. Rückert, Dr. med.

First Name & Middle Initial & Last Name & Degree

Gertrud Feldmann

Facility Name

Franziskus Krankenhaus

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jörg Neymeyer, Dr. med.

Phone

030/26 38-38 01

First Name & Middle Initial & Last Name & Degree

Jörg Neymeyer, Dr. med.

First Name & Middle Initial & Last Name & Degree

Thomas Wülfing, Dr. med.

Facility Name

Helios Klinikum Emil von Behring

City

Berlin

ZIP/Postal Code

14165

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kollmeier Jens, Dr. med.

Phone

030/81 02-14 47

First Name & Middle Initial & Last Name & Degree

Jens Kollmeier, Dr. med.

First Name & Middle Initial & Last Name & Degree

Bettina Schlolaut, Dr. med.

Facility Name

university hospital of Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40255

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Albers, Prof. Dr. med.

Phone

0211/811-81 10

First Name & Middle Initial & Last Name & Degree

Peter Albers, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Jasper Decoene

First Name & Middle Initial & Last Name & Degree

Zenginli Hakan

First Name & Middle Initial & Last Name & Degree

Claus F. Eisenberger, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Wolfram T. Knoefel, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Almut Diem

Facility Name

university hospital of Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Herbert Rübben, Prof. Dr. med.

Phone

0201/723-32 10

First Name & Middle Initial & Last Name & Degree

Herbert Rübben, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Marcus Schenk, Dr. med.

First Name & Middle Initial & Last Name & Degree

Farnk vom Dorp, Dr. med.

First Name & Middle Initial & Last Name & Degree

Min Ju, Dr. med.

First Name & Middle Initial & Last Name & Degree

Stephan Tschirdewahn

First Name & Middle Initial & Last Name & Degree

Michaela Löbert

Facility Name

Ruhrlandklinik Department of Thoracic Surgery

City

Essen

ZIP/Postal Code

45239

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christiane Zimmermann

Phone

0201/433-43 24

First Name & Middle Initial & Last Name & Degree

Georgios Stamatis, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Stefan Welter, Dr. med.

First Name & Middle Initial & Last Name & Degree

Silvia Fechner, Dipl. med.

Facility Name

university hospital of Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrich Wetterauer, Prof. Dr. med.

Phone

0761/270-2891

First Name & Middle Initial & Last Name & Degree

Ulrich Wetterauer, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Christian Leiber, Dr. med.

First Name & Middle Initial & Last Name & Degree

Christian Stremmel, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Jutta Günter, Dr. med.

Facility Name

university Hospital of Heidelberg

City

Heidelberg

ZIP/Postal Code

69119

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markus Hohenfellner, Prof. Dr. med.

Phone

06221/56-63 21

First Name & Middle Initial & Last Name & Degree

Markus Hohenfellner, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Pahernick Sascha, Priv. Doz. Dr. med.

First Name & Middle Initial & Last Name & Degree

Gencay Hatiboglu, Dr. med.

First Name & Middle Initial & Last Name & Degree

Johannes Huber, Dr. Dr. med.

First Name & Middle Initial & Last Name & Degree

Joachim Pfannschmidt, Priv. Doz. Dr. med.

First Name & Middle Initial & Last Name & Degree

Hendrik Dienemann, Prof. Dr. med.

Facility Name

urological hospital of Maria Hilf Krankenhaus Krefeld

City

Krefeld

ZIP/Postal Code

47805

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susanne Krege, Priv. Doz. Dr. med.

Phone

02151/334-52 74

First Name & Middle Initial & Last Name & Degree

Susanne Krege, Priv. Doz. Dr. med.

First Name & Middle Initial & Last Name & Degree

Florian Hartmann, Dr. med.

Facility Name

Hospital of Großhadern

City

München

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Staehler, Dr. med.

Phone

089/70 95-0

First Name & Middle Initial & Last Name & Degree

Michael Staehler, Dr. med.

First Name & Middle Initial & Last Name & Degree

Cordula Nordhaus, Dr. med.

First Name & Middle Initial & Last Name & Degree

Philipp Nuhn, Dr. med.

First Name & Middle Initial & Last Name & Degree

Hauke Winter, Priv. Doz. Dr. med.

First Name & Middle Initial & Last Name & Degree

Rudolf Hatz, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Sylvia Dondl

Facility Name

Dr.-Horst-Schmidt-Kliniken GmbH

City

Wiesbaden

ZIP/Postal Code

65199

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert Frickhofen, Prof. Dr. med.

Phone

0611/43-30 09

First Name & Middle Initial & Last Name & Degree

Norbert Frickhofen, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Bernd Jung, Dr. med.

First Name & Middle Initial & Last Name & Degree

Heinz G. Fuhr, Dr. med.

First Name & Middle Initial & Last Name & Degree

Joachim Schirren, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Servet Bölükbas, Dr. med.

First Name & Middle Initial & Last Name & Degree

Sabine Labenz

First Name & Middle Initial & Last Name & Degree

Birgit Wilde

First Name & Middle Initial & Last Name & Degree

Klaudia Fischbach

12. IPD Sharing Statement

Learn more about this trial

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

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