Renal Cell Carcinoma Clinical Trial
— ROSORCOfficial title:
A Randomized Open Label Multicenter Phase II Study of First Line Therapy With Sorafenib in Association With IL-2 vs Sorafenib Alone in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib and IL-2) versus the standard therapy (sorafenib) in patients affected by different histotypes of metastatic RCC. This study is a first line therapy for the advanced disease. The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the secondary objective is the overall survival (OS) and the response rate (RR) and the safety profile of the combination compared to sorafenib alone.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 2008 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Cytohistological diagnosis of RCC - Written informed consent - Measurable disease according to RECIST criteria - Age >= 18 years - Karnofsky PS >= 60% - Life expectancy of greater than 3 months Exclusion Criteria: - Prior medical treatment for metastatic RCC - Brain metastasis or spinal cord compression - Chronic treatment with corticosteroids - Uncontrolled hypertension |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Tumori | Milano |
Lead Sponsor | Collaborator |
---|---|
Italian Trial in Medical Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | 2 years | Yes |
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---|---|---|---|
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