Skip to main content
. 2023 May 4;2023(5):CD013798. doi: 10.1002/14651858.CD013798.pub2

NCT01835158.

Study characteristics
Methods Study name: CABOSUN
Study design: a two‐arm, RCT, phase II
Blinding: none, open‐label
Study dates: July 9, 2013 to April 6, 2015 (date of randomisation)
Date of data cut‐off: July 01, 2017 (for OS), September 15, 2016 (for PFS per IRC)
Location: 1 country (USA), types of centres: cancer centres/clinics, medical centres, hospitals (488 study locations)
Cross‐over study or cross over permitted: no
Participants Inclusion criteria:

  • 18 years and older

  • all sexes

  • renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required

  • locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to stage IV RCC, according to AJCC staging)

  • eligible participants must be intermediate/poor risk, per the International mRCC Database Consortium (Heng) criteria; participants must therefore have as one or more of the following six factors:

  1. Time from diagnosis of RCC to systematic treatment <1 year

  2. Haemoglobin < the lower limit of normal (ULN)

  3. Corrected calcium > the upper limit of normal (ULN)

  4. Karnosfky performance status < 80%

  5. Neutrophil count > ULN

  6. Latelet count > ULN

  • no prior systemic treatment for RCC; supportive therapies such as bisphosphonates (zoledronic acid) or denosumab are permitted

  • participants must have measurable disease by RECIST criteria; lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan

  • performance status: ECOG 0‐2


Sample size: N = 157
Age (years, median with range): experimental arm: 63 (56‐69) , control arm: 64 (57‐71)
Sex (m/f): experimental arm: 66/13, control arm: 57/21
Prognostic factors:

  • ECOG Performance Status, n(%)

    • 0

      • experimental arm: 36 (46), control arm: 36 (46)

    • 1

      • experimental arm: 33 (42), control arm: 32 (41)

    • 2

      • experimental arm: 10 (13), control arm: 10 (13)

  • IMDC Risk Group

    • Intermediate

      • experimental arm: 64 (81), control arm: 63 (81)

    • Poor

      • experimental arm: 15 (19), control arm: 15 (19)

    • Prior nephrectomy

      • Yes

      • experimental arm: 57 (72), control arm: 60 (77)
Interventions Experimental arm (n = 79): cabozantinib (60 mg, oral, once/day)
Control arm (n = 78): sunitinib (50 mg, oral, once/day)
A treatment cycle was defined as 6 weeks in both study groups (4 weeks on treatment, 2 weeks off).
Outcomes Primary outcome(s)

  • PFS

    • Time frame: up to 5 years

  • OS

    • Time frame: up to 5 years


Secondary outcome(s)

  • Safety (AEs/SAEs)

  • Number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: QoL, TFST
Other outcomes (not relevant to this review): ORR
Notes Funding sources:Quote: "The study was designed by the Alliance for Clinical Trials in Oncology, endorsed by the ECOGeAmerican College of Radiology Imaging Network Group and approved by the Cancer Therapy Evaluation Program of the National Cancer Institute part of the National Institutes of Health (the funder)."
Declaration of Interest: "TKC reports personal fees for an advisory/consulting role from Pfizer, GlaxoSmithKline, Novartis, Merck, Bayer, Eisai, Roche, Prometheus Labs Inc., Foundation Medicine Inc., Bristol‐Myers Squibb, and research funding from Pfizer, GlaxoSmithKline, Novartis, Bristol‐Myers Squibb, Merck, Exelixis Inc., Roche, AstraZeneca, Tracon and Peloton. MDM reports attendance at advisory boards for Pfizer and Exelixis, Inc., outside the submitted work. OH reports relevant financial activities outside the submitted work, and participation at an advisory board for Pfizer. MJM reports attendance at advisory boards for Bayer, Astellas and Progenics, personal fees and research support from Progenics, and research support from Endocyte, outside the submitted work. DRF reports research support from Seattle Genetics and Novartis, outside the submitted work. DG reports personal fees from Dendreon, Novartis, Sanofi, Bayer, Medivation, Biopharm, Axess Oncology, Exelixis, Inc., Pfizer, GlaxoSmithKline, Astellas Pharma, Innocrin Pharma, Bristol‐Myers Squibb, Genentech, Janssen, Acceleron Pharma, Celgene,Merk Sharp & Dohme, and Myovant Sciences, Inc, and research funding from Dendreon, Novartis, Bayer, Exelixis, Inc., Pfizer, Astellas Pharma, Innocrin Pharma, Bristol‐Myers Squibb, Genentech, Janssen, Millennium, Acerta Pharma, outside the submitted work. CH, MM and CS are the employees of Exelixis, Inc. All other authors declare no competing interests."
Clinical study report available: no
Study protocol available: yes
Statistical analysis plan available: no