NCT01069770

Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)

Neoadjuvant Sunitinib Therapy in Patients With Metastatic Clear Cell Type Renal Cell Carcinoma Patients: a Prospective Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Korean Urological Oncology Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces the size of the primary kidney tumor in patients with metastatic disease undergoing cytoreductive surgery. The study will also assess the safety of neoadjuvant Sunitinib, objective response rate, respectability of primary tumor, quality of life, and survival advantages.

Detailed description

Primary objectives : 1\. Response rate of primary tumor based on RECIST criteria Secondary objectives : 1. Resectability based on R0 resection rate (negative margin) 2. Toxicities of therapy with neoadjuvant Sunitinib in renal cell carcinoma 3. Quality of life assessed by EORTC QLQ-C30 questionnaire Korean version 4. To assess the efficacy of neoadjuvant therapy of Sunitinib by evaluating time to progression 5. Overall survival rate after Sunitinib therapy 6. Pathologic evaluation after Sunitinib therapy: the change of necrosis and microvessel density

Conditions

• Clear Cell Renal Cell Carcinoma
• Metastasis

Interventions

Type	Name	Description
DRUG	Sunitinib	50mg daily(4 weeks on \& 2 weeks off), 2 cycles, until progression or unacceptable toxicity develops

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2010-02-17
• Last updated: 2011-06-23

Locations

3 sites across 1 country: South Korea