NCT01216371

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Association of Urologic Oncology (AUO) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Renal Cell Carcinoma
• Pulmonary Metastases

Interventions

Type	Name	Description
DRUG	Sunitinib	one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break
DRUG	Placebo	one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break,

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2010-10-07
• Last updated: 2012-02-13

Locations

11 sites across 1 country: Germany