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

NCT00609401 | Completed Phase 2 DMC

• 1 other identifier: EudraCT number 2006-003137-32
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Disease; Renal Cell Carcinoma

Keywords

Sorafenib; RCC; Metastatic disease

Outcome Measures

Primary Outcomes (1)

• PFS

  2 years

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Nexavar (Sorafenib); Drug: IL-2

2

EXPERIMENTAL

Sorafenib 400 mg bid

Drug: Nexavar (Sorafenib)

Interventions

Nexavar (Sorafenib) DRUG

400 mg bid

1; 2

IL-2 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior medical treatment for metastatic RCC
• Brain metastasis or spinal cord compression
• Chronic treatment with corticosteroids
• Uncontrolled hypertension

Sponsors & Collaborators

• Italian Trial in Medical Oncology: lead

Study Sites (1)

Istituto Tumori

Milan, Italy

Location

Related Publications (2)

• 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.

  PMID: 37146227 DERIVED

• 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.

  PMID: 24063860 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Renal Cell

Interventions

Sorafenib; Interleukin-2

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Giuseppe Procopio, MD

  Istituto Tumori Milano

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: February 7, 2008
• Study Start: November 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2008
• Last Updated: February 26, 2009

Record last verified: 2009-02

Locations

IT (1)