Spots Global Cancer Trial Database for Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)
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Trial Identification
Brief Title: Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)
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 ID: NCT00609401
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Istituto Tumori, Milano, , Italy
Contact Details
Name: Giuseppe Procopio, MD
Affiliation: Istituto Tumori Milano
Role: PRINCIPAL_INVESTIGATOR
Name: E. Aitini, MD
Affiliation: Ospedale di Mantova
Role: STUDY_DIRECTOR
Name: M. Bregni, MD
Affiliation: Ospedale San Raffaele Milano
Role: STUDY_DIRECTOR
Name: G. Conti, MD
Affiliation: Urologia - Ospedale di Como
Role: STUDY_DIRECTOR
Name: M. Maio, MD
Affiliation: Immunologia Oncologica - Ospedale Le Scotte Siena
Role: STUDY_DIRECTOR
Name: G. Fasola, MD
Affiliation: Ospedale di Udine
Role: STUDY_DIRECTOR
Name: V. Zagonel, MD
Affiliation: Medicina Oncologica - Ospedale Fatebenefratelli - Roma
Role: STUDY_DIRECTOR
Name: S. Cascinu, MD
Affiliation: Ospedale di Ancona
Role: STUDY_DIRECTOR
Name: G. Marini, MD
Affiliation: Ospedale di Brescia
Role: STUDY_DIRECTOR
Name: A. Ardizzoia, MD
Affiliation: Ospedale di Monza
Role: STUDY_DIRECTOR
Name: Sergio Ricci, Prof.
Affiliation: Oncologia Medica - Ospedale Santa Chiara Pisa
Role: STUDY_DIRECTOR
Name: L. Cavanna, MD
Affiliation: Oncologia Piacenza
Role: STUDY_DIRECTOR
Name: M. Aglietta, MD
Affiliation: Ospedale di Candiolo Torino
Role: STUDY_DIRECTOR
Name: A. Bertolini, MD
Affiliation: SOC Oncologia Medica Azienda Ospedaliera Valtellina
Role: STUDY_DIRECTOR
Name: Sergio Bracarda, MD
Affiliation: Oncologia Medica Ospedale di Perugia
Role: STUDY_DIRECTOR
Name: L. ISA, MD
Affiliation: A.O. Melegnano - Gorgonzola
Role: STUDY_DIRECTOR
Name: S. Monfardini, MD
Affiliation: Oncologia Ospedale di Padova
Role: STUDY_DIRECTOR
Name: D. Amadori, MD
Affiliation: IOR Ospedale di Forlì
Role: STUDY_DIRECTOR
Name: C. Porta, MD
Affiliation: Ospedale San Matteo Pavia
Role: STUDY_DIRECTOR
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