Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)

Phase 2

Completed

• Conditions: Metastatic Disease; Renal Cell Carcinoma
• Interventions: Drug: Nexavar (Sorafenib); Drug: IL-2

• Registration Number: NCT00609401
• Lead Sponsor: Italian Trial in Medical Oncology

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 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.

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

The trial is stratified according to the MSKCC prognostic model (low intermediate high risk) and histology (Clear cell vs other histotypes). The main inclusion criteria are: cytohistological diagnosis of RCC, measurable disease as RECIST criteria, signed written informed consent, life expectancy of greater than 3 months.

The efficacy and safety analysis will be performed on an intent to treat population.

The anticipated median PFS time in the control arm is 6 months and we will expect an increase of 3 months in the experimental arm.

The sample size is 128 patients, 64 in each arm (1:1 randomization)

The study started in November 2006 and is a multicenter Italian trial.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-05
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-02-07
• Study Completion: 2008-05
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-25
• Last Update Posted: 2009-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

• Prior medical treatment for metastatic RCC
• Brain metastasis or spinal cord compression
• Chronic treatment with corticosteroids
• Uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nexavar (Sorafenib)	Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
1	IL-2	Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
2	Nexavar (Sorafenib)	Sorafenib 400 mg bid

Primary Outcome Measures

Name	Time	Method
PFS	2 years

Trial Locations

Locations (1)

Istituto Tumori; 🇮🇹 Milano, Italy