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. 2020 Oct 14;2020(10):CD012796. doi: 10.1002/14651858.CD012796.pub2

Ravaud 2015.

Study characteristics
Methods Study type: multicentre RCT
Phase: 2
Accrual period: data not found
Blinding: open label design
Strata: MSKCC risk category
IMC: used to analyse tumour responses
Crossover: not allowed
Participants Histology: predominantly clear‐cell mRCC
Prior systemic therapy: treatment‐naïve
Eligible PS: Karnofsky PS 70% or better
Measurable disease: required
Non metastatic %: 0, metastatic disease mandatory
M/F: 269/96
Age median (range): 60 (20 to 84)
Prior nephrectomy: partial or radical nephrectomy mandatory
Prognostic strata: system, good/intermediate/poor risk: MSKCC, 131/208/26
Interventions Everolimus 10 mg po and bevacizumab 10mg/kg iv every 2 wks vs IFN 9 MIU 3 times per wk plus bevacizumab 10 mg/kg every 2 weeks
Outcomes PFS: primary endpoint
OS: secondary outcome
AE: secondary outcome, reported in toxicity table
QoL: not assessed
RR: secondary outcome
Other: duration of response
Funding Sources Industry sponsored
Declarations of interest Reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomized 1:1"
Allocation concealment (selection bias) Unclear risk Data not found
Blinding of participants and personnel (performance bias)
Objective outcomes Low risk "open‐label, phase II RECORD‐2 trial"; personnel and participants were not blinded to treatment, different drug administration forms used, no effect on OS expected
Blinding of participants and personnel (performance bias)
Subjective outcomes Unclear risk "open‐label, phase II RECORD‐2 trial"; personnel and participants were not blinded to treatment, different drug administration forms used
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Tumor response and progression were evaluated by the local radiologist and independent central review
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Tumor response and progression were evaluated by the local radiologist and independent central review; trial design is open‐label
Incomplete outcome data (attrition bias)
PFS, OS Low risk ITT population reported, 3 patients did not receive treatment
Incomplete outcome data (attrition bias)
Response rate Low risk ITT population reported, 3 patients did not receive treatment
Incomplete outcome data (attrition bias)
Serious and minor adverse events Low risk All but 1 participant who received treatment were included in safety analysis
Incomplete outcome data (attrition bias)
Quality of life Unclear risk No available data
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Unclear risk Study not powered to show significant treatment effect