Clinical trial NCT00609401: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Disease
Renal Cell Carcinoma
Keywords: Sorafenib
RCC
Metastatic disease
Lead sponsor: Italian Trial in Medical Oncology
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Tumori
Study officials:
affiliation: Istituto Tumori Milano
name: Giuseppe Procopio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale di Mantova
name: E. Aitini, MD
role: STUDY_DIRECTOR
affiliation: Ospedale San Raffaele Milano
name: M. Bregni, MD
role: STUDY_DIRECTOR
affiliation: Urologia - Ospedale di Como
name: G. Conti, MD
role: STUDY_DIRECTOR
affiliation: Immunologia Oncologica - Ospedale Le Scotte Siena
name: M. Maio, MD
role: STUDY_DIRECTOR
affiliation: Ospedale di Udine
name: G. Fasola, MD
role: STUDY_DIRECTOR
affiliation: Medicina Oncologica - Ospedale Fatebenefratelli - Roma
name: V. Zagonel, MD
role: STUDY_DIRECTOR
affiliation: Ospedale di Ancona
name: S. Cascinu, MD
role: STUDY_DIRECTOR
affiliation: Ospedale di Brescia
name: G. Marini, MD
role: STUDY_DIRECTOR
affiliation: Ospedale di Monza
name: A. Ardizzoia, MD
role: STUDY_DIRECTOR
affiliation: Oncologia Medica - Ospedale Santa Chiara Pisa
name: Sergio Ricci, Prof.
role: STUDY_DIRECTOR
affiliation: Oncologia Piacenza
name: L. Cavanna, MD
role: STUDY_DIRECTOR
affiliation: Ospedale di Candiolo Torino
name: M. Aglietta, MD
role: STUDY_DIRECTOR
affiliation: SOC Oncologia Medica Azienda Ospedaliera Valtellina
name: A. Bertolini, MD
role: STUDY_DIRECTOR
affiliation: Oncologia Medica Ospedale di Perugia
name: Sergio Bracarda, MD
role: STUDY_DIRECTOR
affiliation: A.O. Melegnano - Gorgonzola
name: L. ISA, MD
role: STUDY_DIRECTOR
affiliation: Oncologia Ospedale di Padova
name: S. Monfardini, MD
role: STUDY_DIRECTOR
affiliation: IOR Ospedale di Forlì
name: D. Amadori, MD
role: STUDY_DIRECTOR
affiliation: Ospedale San Matteo Pavia
name: C. Porta, MD
role: STUDY_DIRECTOR
References:
citation: Procopio G, Verzoni E, Bracarda S, Ricci S, Sacco C, Ridolfi L, Porta C, Miceli R, Zilembo N, Bajetta E; Italian Trials in Medical Oncology (ITMO) group. Overall survival for sorafenib plus interleukin-2 compared with sorafenib alone in metastatic renal cell carcinoma (mRCC): final results of the ROSORC trial. Ann Oncol. 2013 Dec;24(12):2967-71. doi: 10.1093/annonc/mdt375. Epub 2013 Sep 24.