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

Association of Urologic Oncology (AUO)11 sites in 1 country60 target enrollmentOctober 2010

ConditionsRenal Cell Carcinoma Pulmonary Metastases

InterventionsSunitinib Placebo

DrugsSunitinib Placebo

Overview

Phase: Phase 2
Intervention: Sunitinib
Conditions: Renal Cell Carcinoma
Sponsor: Association of Urologic Oncology (AUO)
Enrollment: 60
Locations: 11
Primary Endpoint: 2 year relapse-free survival
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

October 2015

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Association of Urologic Oncology (AUO)

Responsible Party

Principal Investigator

Heidrun Rexer

Priv. Doz. Dr. med. Susanne Krege, urological hospital of Maria Hilf Krankenhaus Krefeld

Association of Urologic Oncology (AUO)

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