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

NCT00117637.

Study characteristics
Methods Study name: ‐
Study design: randomised, phase II trial
Blinding: none, open‐label
Study dates: June 28, 2005 ‐ September 30, 2005 (date of randomisation)
Date of data cut‐ off: not reported
Location: 7 countries* (France, Germany, Poland, Russian Federation, Ukraine, UK, USA), types of centres: not reported
Cross‐over study or cross over permitted: yes, cross over trial**
*discrepancies between information provided in the publication and information provided on ct.gov; we included information from ct.gov.
**For cross‐over trials, we only extracted data from the first period.
Participants Inclusion criteria:

  • ECOG PS ≤ 1

  • age ≥ 18 years

  • life expectancy ≥ 12 weeks

  • complete surgical excision of primary RCC at initial diagnosis

  • adequate bone marrow, liver, and renal function assessed 7 days before screening


Exclusion criteria:

  • previous malignancy

  • distinct in primary site/histology from that evaluated in this study

  • complete renal failure that required dialysis

  • symptomatic metastatic brain or meningeal tumours


Sample size: N = 189
Age (median in years (range)): experimental arm: 62 (34‐78), control arm: 62.5 (18‐80)
Sex (m/f): experimental arm: 65/32, control arm: 52/40
Prognostic factors:

  • ECOG PS, n (%)

    • 0

      • experimental arm: 56 (57.7), control arm: 49 (53.3)

    • 1

      • experimental arm: 41 (42.3), control arm: 43 (46.7)

  • MSKCC score, n (%)

    • Low

      • experimental arm: 52 (53.6), control arm: 47 (51.1)

    • Intermediate

      • experimental arm: 44 (45.4), control arm: 44 (47.8)

    • High

      • experimental arm: 1 (1.0), control arm: 0 (0.0)

    • Missing

      • experimental arm: 0 (0.0), control arm: 1 (1.1)

  • Previous nephrectomy (n,%)

    • Yes

      • experimental arm: 95 (97.9), control arm: 83 (90.2)
Interventions Experimental arm (n = 97): Sorafenib (400mg, oral, twice/day)
Control arm (n = 92): Interferona alfa (9 MIU, subcutaneous injection, thrice/week)
Outcomes Primary outcome(s)

  • PFS


Secondary outcome(s)

  • Safety (AEs, SAEs)

  • QoL

  • number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: OS, TFST
Other outcomes (not relevant to this review): response duration, OR, DCR, CR
Notes Funding sources: Thomas E. Hutson, Bayer/Onyx, Pfizer Inc, Wyeth; MichaelStaehler, Bayer Healthcare, Pfizer Inc, Roche, Novartis, Wyeth; DavidCella, Bayer Healthcare; Ronald Bukowski, Bayer Healthcare, Wyeth,Novartis
Declarations of interests: quote: "Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a “U” are those for which no compensation was received; those relationships marked with a “C” were compensated. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no