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

Jonasch 2010.

Study characteristics
Methods Study name: ‐ (NCT also not available)
Study design: randomised, phase II trial
Blinding: no information
Study dates: June 24, 2005 ‐ June 18, 2007 (date of enrolment)
Date of data cut‐off: not reported
Location:USA.; type of centre: cancer centre (1 study location)
Cross‐over study or cross over permitted: not per design; not reported whether cross over was permitted at some point (e.g. upon progression)
Participants Inclusion criteria:

  • pathologically confirmed metastatic clear cell RCC

  • no prior systemic therapy

  • ECOG PS of 0 or 1

  • no brain metastases

  • measurable disease according to RECIST


Sample size: N = 80
Age, median in years (range): experimental arm: 60.7 (43‐81), control arm: 62.4 (45‐83)
Sex (m/f): experimental arm: 29/11, control arm: 32/8
Prognostic factors:

  • ECOG status, n (%)

    • 0

      • experimental arm: 25 (62.5), control arm: 25 (62.5)

    • 1

      • experimental arm: 15 (37.5), control arm: 15 (37.5)

  • MSKCC prognostic risk, n (%)

    • Low

      • experimental arm: 20 (50), control arm: 21 (52.5),

    • Intermediate

      • experimental arm: 18 (45), control arm: 19 (47.5),

    • Poor

      • experimental arm: 2 (5), control arm: 0

  • Previous nephrectomy (N,%)

    • Yes

      • experimental arm: 40 (100), control arm: 39 (98)
Interventions Experimental arm (n = 40): Sorafenib 400 mg (oral, twice/day) + Interferon alfa (0.5 MIU, subcutaneous injection, twice/day)
Control arm (n = 40): Sorafenib, 400mg (oral, twice/day)
Outcomes Primary outcome(s)

  • Safety (report "toxicities")


Secondary outcome(s)

  • Progression‐free survival (PFS)

  • Overall survival (OS)


Outcomes relevant to this review but not reported: QoL; TFST; number of participants who discontinued treatment due to an AE
Other outcomes (not relevant to this review): ORR
Notes Funding sources: National Cancer Institute’s Cancer Therapy Evaluation Program
Conflict of interest disclosures: "Supported by the National Cancer Institute’s Cancer Therapy Evaluation Program."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no