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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609401
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 26, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Metastatic Disease Renal Cell Carcinoma Drug: Nexavar (Sorafenib) Drug: IL-2 Phase 2

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  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2006
Primary Completion Date : May 2007
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609401

Istituto Tumori
Milano, Italy
Sponsors and Collaborators
Italian Trial in Medical Oncology
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Giuseppe Procopio, ITMO Identifier: NCT00609401     History of Changes
Other Study ID Numbers: EudraCT number 2006-003137-32
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009

Keywords provided by Italian Trial in Medical Oncology:
Metastatic disease

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs