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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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

Sponsor: Korean Urological Oncology Society

Current Primary Outcome: Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival rate after Sunitinib therapy [ Time Frame: 2 years ]
  • Pathologic evaluation after Sunitinib therapy [ Time Frame: After nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment) ]
  • Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire (Korean version) [ Time Frame: 2 years ]
  • Resectability based on R0 resection rate [ Time Frame: on nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment) ]


Original Secondary Outcome: Same as current

Information By: Korean Urological Oncology Society

Dates:
Date Received: February 12, 2010
Date Started: July 2009
Date Completion: June 2012
Last Updated: June 21, 2011
Last Verified: June 2011