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

NCT00979966.

Study characteristics
Methods Study name: ‐
Study design: RCT, parallel assignment, phase II
Blinding: none, open‐label
Study dates: July 2009 ‐ July 2012
Date of data cut‐off: not reported
Location: 1 country (Germany), types of centres: clinics, university hospitals (14 study locations)
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:

  • adult males and females: ≥18 years of age.

  • locally advanced or metastatic, histological confirmed, non‐clear cell RCC of all subtypes. participants must have advanced non‐clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.

  • participants with measurable disease (at least one uni‐dimensionally measurable target lesion by CT‐scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) If prior palliative radiotherapy to metastatic lesions: ≥ 1 measurable lesion that has not been irradiated.

  • PS 0‐2 ECOG


Exclusion criteria:

  • predominant clear‐cell RCC

  • resectability or other curative options

  • any investigational drug within the 30 days before inclusion.

  • prior systemic treatment for their RCC.

  • known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.

  • radiotherapy within the last 4 weeks.

  • pregnancy (absence to be confirmed by beta‐hCG test) or lactation period.

  • men or women of child‐bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.

  • clinically symptomatic brain or meningeal metastasis (known or suspected)


More inclusion and exclusion criteria on CT.gov.
Sample size: N = 22
Age, mean (range): experimental arm: 57.4 (29‐85), control arm: 64.8 (46‐80)
Sex (m/f): experimental arm: 8/4, control arm: 8/2
Prognostic factors:

  • ECOG Performance Scale, n

    • 0

      • experimental arm: 7, control arm: 6

    • 1

      • experimental arm: 5, control arm: 4

  • Previous nephrectomy, n(%)

    • Yes

      • total population: 106 (85.5)
Interventions Experimental arm (n = 12): temsirolimus (25 mg, intravenous, once/week)
Control arm (n = 10): sunitinib (50 mg, oral, once/day)
Outcomes Primary outcome(s)
‐
Secondary outcome(s)

  • safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs (time frame: 8‐12 months (treatment duration + 1 months))

  • one year PFS rate (time frame: 1 year)

  • overall survival (OS) (time frame: will be evaluated in 2013)

  • Number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: TFST
Other outcomes (not relevant to this review): OR, TTP, CR/PR, RB
Notes Funding sources: This study was supported by a grant from Pfizer Germany.
Declarations of Interests: Full details provided in Bergmann (2020).
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no