Spots Global Cancer Trial Database for Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT01069770

Conditions

Clear Cell Renal Cell Carcinoma

Metastasis

Interventions

Sunitinib

Study Description

Brief 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