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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)

NCT ID: NCT00609401

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Metastatic Disease Renal Cell Carcinoma

Keywords

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Sorafenib RCC Metastatic disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4

Group Type EXPERIMENTAL

Nexavar (Sorafenib)

Intervention Type DRUG

400 mg bid

IL-2

Intervention Type DRUG

IL-2 3 MU per 5 day/week for 2 weeks every 4

2

Sorafenib 400 mg bid

Group Type EXPERIMENTAL

Nexavar (Sorafenib)

Intervention Type DRUG

400 mg bid

Interventions

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Nexavar (Sorafenib)

400 mg bid

Intervention Type DRUG

IL-2

IL-2 3 MU per 5 day/week for 2 weeks every 4

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Trial in Medical Oncology

OTHER

Sponsor Role lead

Responsible Party

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ITMO

Principal Investigators

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Giuseppe Procopio, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Tumori Milano

E. Aitini, MD

Role: STUDY_DIRECTOR

Ospedale di Mantova

M. Bregni, MD

Role: STUDY_DIRECTOR

Ospedale San Raffaele Milano

G. Conti, MD

Role: STUDY_DIRECTOR

Urologia - Ospedale di Como

M. Maio, MD

Role: STUDY_DIRECTOR

Immunologia Oncologica - Ospedale Le Scotte Siena

G. Fasola, MD

Role: STUDY_DIRECTOR

Ospedale di Udine

V. Zagonel, MD

Role: STUDY_DIRECTOR

Medicina Oncologica - Ospedale Fatebenefratelli - Roma

S. Cascinu, MD

Role: STUDY_DIRECTOR

Ospedale di Ancona

G. Marini, MD

Role: STUDY_DIRECTOR

Ospedale di Brescia

A. Ardizzoia, MD

Role: STUDY_DIRECTOR

Ospedale di Monza

Sergio Ricci, Prof.

Role: STUDY_DIRECTOR

Oncologia Medica - Ospedale Santa Chiara Pisa

L. Cavanna, MD

Role: STUDY_DIRECTOR

Oncologia Piacenza

M. Aglietta, MD

Role: STUDY_DIRECTOR

Ospedale di Candiolo Torino

A. Bertolini, MD

Role: STUDY_DIRECTOR

SOC Oncologia Medica Azienda Ospedaliera Valtellina

Sergio Bracarda, MD

Role: STUDY_DIRECTOR

Oncologia Medica Ospedale di Perugia

L. ISA, MD

Role: STUDY_DIRECTOR

A.O. Melegnano - Gorgonzola

S. Monfardini, MD

Role: STUDY_DIRECTOR

Oncologia Ospedale di Padova

D. Amadori, MD

Role: STUDY_DIRECTOR

IOR Ospedale di Forlì

C. Porta, MD

Role: STUDY_DIRECTOR

Ospedale San Matteo Pavia

Locations

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Istituto Tumori

Milan, , Italy

Site Status

Countries

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Italy

References

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Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

Reference Type DERIVED
PMID: 37146227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24063860 (View on PubMed)

Related Links

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http://www.istitutotumori.mi.it

Related Info

Other Identifiers

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EudraCT number 2006-003137-32

Identifier Type: -

Identifier Source: secondary_id

EudraCT number 2006-003137-32

Identifier Type: -

Identifier Source: org_study_id