Trial document




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  DRKS00003518

Trial Description

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Title

Prospective randomized multicenter phase II study of pulmonalfiliae metastases (poor-prognosis) in clear cell renal cell carcinoma + / - adjuvant Sunitinibtherapie than 1 year - SMAT - AN 20/04

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Trial Acronym

SMAT

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URL of the Trial

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Brief Summary in Lay Language

Study to complete or partial removal of the lung metastases after surgical removal of the kidney with a then following treatment with tablets. (Metastases from a primary tumor are spatially separate, similar metastases caused by carryover of viable tumor cells.). The goal is the 2-year survival without new metastases appear to investigate. Included are patients with> / = 2 synchronous lung metastases or exhibit lung metastases within 24 months after surgical removal of a kidney.

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Brief Summary in Scientific Language

Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma

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Organizational Data

  •   DRKS00003518
  •   2012/01/30
  •   2010/10/06
  •   yes
  •   Approved
  •   2010207, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   2008-007609-36 
  •   NCT01216371  (ClinicalTrials.gov)
  •   4036290 
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Health Condition or Problem studied

  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
  •   C78.0 -  Secondary malignant neoplasm of lung
  •   kidney cancer
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Interventions/Observational Groups

  •   one year adjuvant treatment: oral 50 mg sunitinib pills (Sutent®) for 4 weeks, then 2 weeks rest period
  •   one year treatment: oral 50 mg placebo pills for 4 weeks, then 2 weeks rest period
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
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  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

2 year relapse-free survival

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Secondary Outcome

- 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 ] [

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/11/26
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- 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

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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

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Krankenhaus Maria-Hilf Krefeld
    • Ms.  Prof. Dr.  Susanne  Krege 
    • Oberdießemer Straße 94
    • 47805  Krefeld
    • Germany
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    • Krankenhaus Maria-Hilf Krefeld
    • Ms.  Prof. Dr.  Susanne  Krege 
    • Oberdießemer Straße 94
    • 47805  Krefeld
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.