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 |
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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 |
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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 |
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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 |