Clinical trial NCT01216371: Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Pulmonary Metastases
Keywords: carcinoma
metastases
renal
lung
Lead sponsor: Association of Urologic Oncology (AUO)
Sponsor class: OTHER
Collaborators: name: University Hospital, Essen
First posted: 2010-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.

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 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

Primary outcomes:
measure: 2 year relapse-free survival
timeFrame: 5 years
Secondary outcomes:
measure: perioperative mortality and morbidity
timeFrame: 5 years
measure: Side effect of adjuvant therapy
timeFrame: 5 years
measure: Quality of Life of the Patient
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Charité Berlin
city: Berlin
country: Germany
facility: Franziskus Krankenhaus
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
city: Düsseldorf
country: Germany
facility: university hospital of Düsseldorf
city: Essen
country: Germany
facility: university hospital of Essen
city: Essen
country: Germany
facility: Ruhrlandklinik Department of Thoracic Surgery
city: Freiburg
country: Germany
facility: university hospital of Freiburg
city: Heidelberg
country: Germany
facility: university Hospital of Heidelberg
city: Krefeld
country: Germany
facility: urological hospital of Maria Hilf Krankenhaus Krefeld
city: München
country: Germany
facility: Hospital of Großhadern
city: Wiesbaden
country: Germany
facility: Dr.-Horst-Schmidt-Kliniken GmbH
Study officials:
affiliation: urological hospital of Maria Hilf Krankenhaus Krefeld
name: Susanne Krege, Priv. Doz. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: