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

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.

Conditions

• Metastatic Disease
• Renal Cell Carcinoma

Interventions

DRUG

Nexavar (Sorafenib)

400 mg bid

DRUG

IL-2

IL-2 3 MU per 5 day/week for 2 weeks every 4

Sponsors & Collaborators

• Italian Trial in Medical Oncology

  lead OTHER

Principal Investigators

• Giuseppe Procopio, MD · Istituto Tumori Milano

• E. Aitini, MD · Ospedale di Mantova

• M. Bregni, MD · Ospedale San Raffaele Milano

• G. Conti, MD · Urologia - Ospedale di Como

• M. Maio, MD · Immunologia Oncologica - Ospedale Le Scotte Siena

• G. Fasola, MD · Ospedale di Udine

• V. Zagonel, MD · Medicina Oncologica - Ospedale Fatebenefratelli - Roma

• S. Cascinu, MD · Ospedale di Ancona

• G. Marini, MD · Ospedale di Brescia

• A. Ardizzoia, MD · Ospedale di Monza

• Sergio Ricci, Prof. · Oncologia Medica - Ospedale Santa Chiara Pisa

• L. Cavanna, MD · Oncologia Piacenza

• M. Aglietta, MD · Ospedale di Candiolo Torino

• A. Bertolini, MD · SOC Oncologia Medica Azienda Ospedaliera Valtellina

• Sergio Bracarda, MD · Oncologia Medica Ospedale di Perugia

• L. ISA, MD · A.O. Melegnano - Gorgonzola

• S. Monfardini, MD · Oncologia Ospedale di Padova

• D. Amadori, MD · IOR Ospedale di Forlì

• C. Porta, MD · Ospedale San Matteo Pavia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2007-05-31

Completion

2008-05-31

Countries

• Italy

Study Locations