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

This study has been completed.
Sponsor:
Information provided by:
Italian Trial in Medical Oncology
ClinicalTrials.gov Identifier:
NCT00609401
First received: January 11, 2008
Last updated: February 25, 2009
Last verified: February 2009
History of Changes

January 11, 2008
February 25, 2009
November 2006
May 2007   (final data collection date for primary outcome measure)
PFS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
PFS [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00609401 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Disease
  • Renal Cell Carcinoma
  • Drug: Nexavar (Sorafenib)
    400 mg bid
    Other Name: Nexavar (Sorafenib)
  • Drug: IL-2
    IL-2 3 MU per 5 day/week for 2 weeks every 4
  • Experimental: 1
    Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
    Interventions:
    • Drug: Nexavar (Sorafenib)
    • Drug: IL-2
  • Experimental: 2
    Sorafenib 400 mg bid
    Intervention: Drug: Nexavar (Sorafenib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
May 2008
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00609401
EudraCT number 2006-003137-32, EudraCT number 2006-003137-32
Yes
Giuseppe Procopio, ITMO
Italian Trial in Medical Oncology
Not Provided
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
Italian Trial in Medical Oncology
February 2009

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