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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Association of Urogenital Oncology (AUO).
Recruitment status was:  Recruiting
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
  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
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 ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Germany
Universitätsmedizin Charité Berlin
Berlin, Germany, 10117
Franziskus Krankenhaus
Berlin, Germany, 10787
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
university hospital of Düsseldorf
Düsseldorf, Germany, 40255
university hospital of Essen
Essen, Germany, 45122
Ruhrlandklinik Department of Thoracic Surgery
Essen, Germany, 45239
university hospital of Freiburg
Freiburg, Germany, 79106
university Hospital of Heidelberg
Heidelberg, Germany, 69119
urological hospital of Maria Hilf Krankenhaus Krefeld
Krefeld, Germany, 47805
Hospital of Großhadern
München, Germany, 81377
Dr.-Horst-Schmidt-Kliniken GmbH
Wiesbaden, Germany, 65199
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

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

Keywords provided by 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

ClinicalTrials.gov processed this record on February 17, 2017