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

February 25, 2009 updated by: Italian Trial in Medical Oncology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Istituto Tumori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
Drug: Nexavar (Sorafenib)
400 mg bid
Drug: IL-2
IL-2 3 MU per 5 day/week for 2 weeks every 4
Experimental: 2
Sorafenib 400 mg bid
Drug: Nexavar (Sorafenib)
400 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Trial in Medical Oncology

Investigators

  • Principal Investigator: Giuseppe Procopio, MD, Istituto Tumori Milano
  • Study Director: E. Aitini, MD, Ospedale di Mantova
  • Study Director: M. Bregni, MD, Ospedale San Raffaele Milano
  • Study Director: G. Conti, MD, Urologia - Ospedale di Como
  • Study Director: M. Maio, MD, Immunologia Oncologica - Ospedale Le Scotte Siena
  • Study Director: G. Fasola, MD, Ospedale di Udine
  • Study Director: V. Zagonel, MD, Medicina Oncologica - Ospedale Fatebenefratelli - Roma
  • Study Director: S. Cascinu, MD, Ospedale di Ancona
  • Study Director: G. Marini, MD, Ospedale di Brescia
  • Study Director: A. Ardizzoia, MD, Ospedale di Monza
  • Study Director: Sergio Ricci, Prof., Oncologia Medica - Ospedale Santa Chiara Pisa
  • Study Director: L. Cavanna, MD, Oncologia Piacenza
  • Study Director: M. Aglietta, MD, Ospedale di Candiolo Torino
  • Study Director: A. Bertolini, MD, SOC Oncologia Medica Azienda Ospedaliera Valtellina
  • Study Director: Sergio Bracarda, MD, Oncologia Medica Ospedale di Perugia
  • Study Director: L. ISA, MD, A.O. Melegnano - Gorgonzola
  • Study Director: S. Monfardini, MD, Oncologia Ospedale di Padova
  • Study Director: D. Amadori, MD, IOR Ospedale di Forlì
  • Study Director: C. Porta, MD, Ospedale San Matteo Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2009

Last Update Submitted That Met QC Criteria

February 25, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number 2006-003137-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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