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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609401
Other study ID # EudraCT number 2006-003137-32
Secondary ID EudraCT number 2
Status Completed
Phase Phase 2
First received January 11, 2008
Last updated February 25, 2009
Start date November 2006
Est. completion date May 2008

Study information

Verified date February 2009
Source Italian Trial in Medical Oncology
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics CommitteeItaly: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 2008
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Nexavar (Sorafenib)
400 mg bid
IL-2
IL-2 3 MU per 5 day/week for 2 weeks every 4

Locations

Country Name City State
Italy Istituto Tumori Milano

Sponsors (1)

Lead Sponsor Collaborator
Italian Trial in Medical Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary PFS 2 years Yes
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