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. 2023 May 4;2023(5):CD013798. doi: 10.1002/14651858.CD013798.pub2

NCT00609401.

Study characteristics
Methods Study name: ROSORC
Study design: randomised, phase II
Blinding: none, open‐label
Study dates: October 2006 ‐ February 2008 (date of enrolment)
Date of data cut‐off: September 30, 2012 (for OS)
Location: 1 country (Italy), types of centres: not reported, but multicentre study
Cross‐over study or cross over permitted: not a cross‐over study; not reported whether cross over was permitted at some point (e.g. upon progression)
Participants Inclusion criteria:

  • age >= 18 years

  • all sexes

  • Karnofsky PS >= 60%

  • cytohistological diagnosis of RCC

  • written informed consent

  • measurable disease according to RECIST criteria v. 1.0

  • life expectancy of greater than 3 months and an Eastern Cooperative Oncology Group performance status ≤2

  • histologically based diagnosis of mRCC

  • participants had not been previously treated with systemic therapy for metastatic disease, but they could have undergone nephrectomy


Exclusion criteria:

  • history of brain metastases

  • presence of concomitant illnesses

  • medical conditions like unstable angina, uncontrolled hypertension, unstable diabetes mellitus, or potentially life‐threatening autoimmune disorders


Sample size: N = 128
Age (years, median with range): experimental arm: 64 (57‐69), control arm: 62 (52‐69)
Sex (m/f): experimental arm: 52/14, control arm: 43/19
Prognostic factors:

  • MSKCC risk group, n(%)

    • Low

      • experimental arm: 36 (55), control arm: 34 (55)

    • Intermediate

      • experimental arm: 27 (41), control arm: 24 (39)

    • High

      • experimental arm: 3 (5), control arm: 4 (6)

  • Prior nephrectomy n(%)

    • Yes

      • experimental arm: 48 (73), control arm: 46 (74)
Interventions Experimental arm (n = 66): sorafenib (400 mg, oral, twice/day) + IL‐2 (3 MIU, subcutaneous injection, 5 days/week)Control arm (n = 62): Sorafenib (400mg, oral, twice/day)
Outcomes Primary outcome(s)

  • PFS

    • Time frame: 2 years


Secondary outcome(s)

  • OS

  • Safety


Relevant to this review but not reported: QoL,TFST, number of participants who discontinued treatment
Other outcomes (not relevant to this review): ORR
Notes Funding sources: editorial assistance for this manuscript was provided by Dragonfly Editorial, funded by Bayer HealthCare. This study was supported in part by Bayer HealthCare.
Declarations of Interests: Quote: "The authors have declared no conflicts of interest."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no