NCT01064310.

Study characteristics
Methods	Study name: PISCES Study design: randomised, phase III b Blinding: quadruple (participant, care provider, investigator, outcomes assessor) Study dates: May 2010 – October 2011 Date of data cut‐off: not reported Location: 5 countries (Finland, France, Germany, Italy, UK), types of centres: not reported (51 study locations) Cross‐over study or cross over permitted: yes, cross‐over study* *For cross‐over studies, we only extracted data on period 1.
Participants	Inclusion criteria: participants ≥ 18 years of age all sexes no prior systemic therapy locally advanced or metastatic renal cell carcinoma of any histology ECOG PS 0 or 1 Exclusion criteria: poor MSKCC risk group history of another malignancy Sample size: N=169* (*) One patient was randomly assigned in error, and no data were entered into the study for this patient; data were available for 168 participants. Age (years, median): experimental arm: 64, control arm: 62 Sex (male/f): experimental arm: 61/3, control arm: 52/10 Prognostic factors: ECOG PS, n (%) 0 experimental arm: 60 (70), control arm: 61 (74) 1 experimental arm: 26 (30), control arm: 21 (26) Previous nephrectomy (n,%) Yes experimental arm 70 (85), control arm 79 (92)
Interventions	Experimental arm (n = 86): pazopanib (800 mg, oral, once/day) ‐ 10 weeks on treatment, followed by 2 weeks wash‐out Control arm (n = 82): sunitinib (50 mg, oral, once/day) ‐ 4 weeks on treatment, 2 weeks placebo, followed by another 4 weeks on treatment
Outcomes	Primary outcome(s) ‐ Secondary outcome(s) Quality of Life as assessed by the EuroQoL‐5 Dimensions (EQ‐5D) Thermometer and Utility Scores and FACIT‐Fatigue Time frame: Day 1 (Period 1 Pre‐dose); during 2‐week Wash‐out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22]) Number of participants with grade 1 to grade 5 (AEs) Time frame: baseline to end of study (maximum of 22 weeks) Number of participants with the indicated AEs leading to permanent discontinuation of study treatment Time frame: baseline to end of study (maximum of 22 weeks) Number of participants who discontinued treatment due to an AE Relevant to this review but not reported: PFS, OS, TFST Other outcomes (not relevant to this review): number of participants with preference for pazopanib versus sunitinib as assessed by the Patient Preference Questionnaire (PPQ), (BL), dose reduction, dose modification
Notes	Funding sources: Novartis Pharmaceuticals, Camillo Porta, Bayer Schering Pharma, Novartis, Pfizer; Petri Bono, GlaxoSmithKline, Pfizer; Thomas Powles, GlaxoSmithKline, Pfizer; Tim Eisen, Bayer AG, Pfizer, GlaxoSmithKline; Robert Hawkins, Pfizer, GlaxoSmithKline; David Cella, GlaxoSmithKline, Pfizer, AVEO Pharmaceuticals Declaration of Interest: Quote: "Although all authors completed the disclosure declaration, the following author(s) and/or an author’s immediate family member(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. (...)For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors." Clinical study report available: only a 'scientific result summary' available Study protocol available: yes Statistical analysis plan available: yes