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

NCT00732914.

Study characteristics
Methods Study name: SWITCH
Study design: a two‐arm, randomised, phase III
Blinding: none, open‐label
Study dates: February 2009 ‐ December 2011 (date of randomisation)
Date of data cut‐off: August 15, 2013 (primary analysis) (data used in this review); January 14, 2014 (post‐hoc analysis of OS)
Location: 1 country (Germany), types of centres: urology clinic (1 study location)
Cross‐over study or cross over permitted: yes, cross‐over study*
*For cross over trials we only extracted data from the first period.
Participants Inclusion criteria:

  • participants with metastatic / advanced RCC (all histologies), who are not suitable for cytokine therapy and for whom study medication constitutes first‐line therapy

  • age >= 18 and <= 85years

  • ECOG PS of 0 or 1

  • MSKCC prognostic score, low or intermediate

  • life expectancy of at least 12 weeks

  • participants with at least one uni‐dimensional (for RECIST) measurable lesion. Lesions must be measured by CT/MRI‐scan.


Exclusion criteria:

  • history of cardiac disease: congestive heart failure

  • history of HIV infection or chronic hepatitis B or C

  • active clinically serious infections (> grade 2 NCI‐CTC version 3.0)

  • symptomatic metastatic brain or meningeal tumours (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumour at the time of study entry)

  • known allergy to sunitinib or sorafenib or one of its constituents


Excluded therapies and medications, previous and concomitant:

  • anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry

  • radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study

  • investigational drug therapy outside of this trial during or within 4 weeks of study entry

  • prior exposure to the study drug


Sample size: N =365
Median age (years, range): experimental arm: 63 (39‐84), control arm: 65 (40‐83)
Sex (m/f): experimental arm: 139/43, control arm: 135/48
Prognostic factors:

  • Nephrectomy, n(%)

    • Yes

      • experimental arm: 167 (92), control arm: 168 (92)

  • MSKCC risk score, n(%)

    • High

      • experimental arm: 1 (0.5), control arm: 1 (0.5)

    • Intermediate

      • experimental arm: 108 (59), control arm: 94 (51)

    • Favourable

      • experimental arm: 71 (39), control arm: 82 (45)

    • Unknown

      • experimental arm: 2 (1.1), control arm: 4 (2.2)

    • Missing

      • experimental arm: 0 (0), control arm: 2 (1.1)

  • ECOG performance scale, n(%)

    • 0

      • experimental arm: 116 (66), control arm: 106 (60)

    • 1

      • experimental arm: 55 (31), control arm: 66 (38)

    • 2

      • experimental arm: 0 (0), control arm: 1 (0.6)

    • Missing

      • experimental arm: 6 (3.4), control arm: 3 (1.7)
Interventions Experimental arm (n = 182): Sorafenib (400 mg, oral, twice/day)
Control arm ( n =183): Sunitinib (50 mg, oral, once/day)
Outcomes Primary outcome(s)

  • First‐line* PFS


Secondary outcome(s)

  • Safety (AE, SAE) in the first‐line treatment

  • Number of participants who discontinued treatment due to an AE during first‐line treatment


Relevant to this review but not reported: first‐line OS, QoL, TFST
Other outcomes (not relevant to this review): OS (after second‐line treatment), time to progression (TTP), DCR (disease control rate), cardiotoxicity
*First‐line refers to first‐line treatment (i.e. period 1 in this cross‐over study).
Notes Funding sources: Bayer, Pfizer, and Novartis quote: :"The SWITCH trial was sponsored by the German Cancer Society (DKG) with a financial grant from Bayer HealthCare. The Main Association of Austrian Social Security Institutions also supported the study. The specific role of the sponsors was in the design and conduct of the study. Bayer HealthCare also funded medical writing support for the preparation of this article."
Declarations of Interests: Quote: "Christian Eichelberg certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (...)."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no