Metastatic DiseasePhase 2ROSORCNCT00609401
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)
A Phase 2 study testing Nexavar (Sorafenib) and IL-2 in people with Metastatic Disease and Renal Cell Carcinoma, run by Italian Trial in Medical Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Disease, Renal Cell Carcinoma
- What is being tested?
- Nexavar (Sorafenib) and IL-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2006to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior medical treatment for metastatic RCC
- Brain metastasis or spinal cord compression
- Chronic treatment with corticosteroids
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Disease, Renal Cell Carcinoma
- Being tested
- Nexavar (Sorafenib), IL-2
- Keywords
- Sorafenib, RCC, Metastatic disease
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexavar (Sorafenib)Drug
400 mg bid
IL-2Drug
IL-2 3 MU per 5 day/week for 2 weeks every 4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4 Receives: Drug: Nexavar (Sorafenib); Drug: IL-2 |
| 2 | Experimental | Sorafenib 400 mg bid Receives: Drug: Nexavar (Sorafenib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Trial in Medical Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Procopio, MD, Principal investigator, Istituto Tumori MilanoE. Aitini, MD, Study director, Ospedale di MantovaM. Bregni, MD, Study director, Ospedale San Raffaele MilanoG. Conti, MD, Study director, Urologia - Ospedale di ComoM. Maio, MD, Study director, Immunologia Oncologica - Ospedale Le Scotte SienaG. Fasola, MD, Study director, Ospedale di UdineV. Zagonel, MD, Study director, Medicina Oncologica - Ospedale Fatebenefratelli - RomaS. Cascinu, MD, Study director, Ospedale di Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609401
- Sponsor's protocol ID
- EudraCT number 2006-003137-32
- Other IDs
- EudraCT number 2006-003137-32
- Acronym
- ROSORC
- Status last verified
- Feb 2009
- First submitted
- 11 Jan 2008
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37146227Procopio 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.
PubMed 24063860
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00609401
- Acronym / sponsor ID
- ROSORC / EudraCT number 2006-003137-32
- Conditions
- Metastatic Disease, Renal Cell Carcinoma
- Keywords
- Sorafenib, RCC, Metastatic disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Italian Trial in Medical OncologyUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nexavar (Sorafenib), Drug: IL-2Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4 |
| 2 | Experimental | Drug: Nexavar (Sorafenib)Sorafenib 400 mg bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cytohistological diagnosis of RCC
- Written informed consent
- Measurable disease according to RECIST criteria
- Age >= 18 years
- Karnofsky PS >= 60%
Key exclusion criteria (4 listed)
- Prior medical treatment for metastatic RCC
- Brain metastasis or spinal cord compression
- Chronic treatment with corticosteroids
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexavar (Sorafenib)400 mg bid | Drug | 1, 2 |
| IL-2IL-2 3 MU per 5 day/week for 2 weeks every 4 | Drug | 1 |
Primary outcome
PFS
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
- Derived from this study: PubMed 37146227Aldin 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.
- Derived from this study: PubMed 24063860Procopio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Procopio, MD principal investigator
Istituto Tumori Milano
E. Aitini, MD study director
Ospedale di Mantova
M. Bregni, MD study director
Ospedale San Raffaele Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexavar (Sorafenib) and IL-2 in people with Metastatic Disease and Renal Cell Carcinoma, run by Italian Trial in Medical Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2009.