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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Renal Cell Carcinoma, Pulmonary Metastases

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

2 year relapse-free survival

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Susanne Krege, Priv. Doz. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

urological hospital of Maria Hilf Krankenhaus Krefeld

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AN 20/04

NCT ID:

NCT01216371

Start Date:

October 2010

Completion Date:

October 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Pulmonary Metastases
  • carcinoma
  • metastases
  • renal
  • lung
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis
  • Lung Neoplasms

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