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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-003137-32 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4 |
|
| 2 | Experimental | Sorafenib 400 mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexavar (Sorafenib) | Drug | 400 mg bid |
| |
| IL-2 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Tumori | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37146227 | Derived | 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. | |
| 24063860 |
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| Drug |
IL-2 3 MU per 5 day/week for 2 weeks every 4 |
|
| 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 |
| 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. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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