Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)
This study is currently recruiting participants.
Verified February 2012 by Association of Urogenital Oncology (AUO)
Sponsor:
Association of Urogenital Oncology (AUO)
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
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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:
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
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 | |
| 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. | |
| 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. | |
| 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 Carcinoma, Renal Cell Neoplasm Metastasis Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplastic Processes |
Pathologic Processes Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adjuvants, Immunologic Sunitinib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013