Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT) (SMAT)
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ClinicalTrials.gov Identifier: NCT01216371 |
Recruitment Status
: Unknown
Verified February 2012 by Heidrun Rexer, Association of Urogenital Oncology (AUO).
Recruitment status was: Recruiting
First Posted
: October 7, 2010
Last Update Posted
: February 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Cell Carcinoma Pulmonary Metastases | Drug: Sunitinib Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sunitinib
one year adjuvant treatment with sunitinib
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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
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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
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- 2 year relapse-free survival [ Time Frame: 5 years ]
- perioperative mortality and morbidity [ Time Frame: 5 years ]
- Side effect of adjuvant therapy [ Time Frame: 5 years ]
- Quality of Life of the Patient [ Time Frame: 5 years ]
- Overall Survival [ Time Frame: 5 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216371
Contact: Susanne Krege, Priv. Doz. Dr. med. | 02 151 / 334-23 81 |
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 |
Principal Investigator: | Susanne Krege, Priv. Doz. Dr. med. | urological hospital of Maria Hilf Krankenhaus Krefeld |
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 ( EudraCT Number ) |
First Posted: | October 7, 2010 Key Record Dates |
Last Update Posted: | February 13, 2012 |
Last Verified: | February 2012 |
Keywords provided by Heidrun Rexer, Association of Urogenital 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 |