Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)
NCT01069770 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2011-06-23
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.
Conditions
- Clear Cell Renal Cell Carcinoma
- Metastasis
Interventions
- DRUG
-
Sunitinib
50mg daily(4 weeks on \& 2 weeks off), 2 cycles, until progression or unacceptable toxicity develops
Sponsors & Collaborators
- collaborator INDUSTRY
-
Korean Urological Oncology Society
lead OTHER
Principal Investigators
-
Sungjoon Hong, M.D., Ph.D · The Korean Urological Oncology Society
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2011-12-31
- Completion
- 2012-06-30
Countries
- South Korea
Study Locations
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