Status:
COMPLETED
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)
Lead Sponsor:
Italian Trial in Medical Oncology
Conditions:
Metastatic Disease
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 metastat...
Detailed Description
Patients will be allocated in 2 groups: ARM A - Sorafenib 400 mg twice daily continuously and low dose of IL-2 administered s.c. ARM B - Sorafenib alone at the same dosage used in the previous arm ...
Eligibility Criteria
Inclusion
- 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
- Prior medical treatment for metastatic RCC
- Brain metastasis or spinal cord compression
- Chronic treatment with corticosteroids
- Uncontrolled hypertension
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00609401
Start Date
November 1 2006
End Date
May 1 2008
Last Update
February 26 2009
Active Locations (1)
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1
Istituto Tumori
Milan, Italy