The STAT-ROC feasibility study

Study hypothesis: This study is a single-centre, blinded, parallel group, randomised controlled trial to determine the feasibility of investigating adjuvant statin therapy in the prevention of post-operative recurrence of oesophageal and gastro-oesophageal adenocarcinoma in a future phase III RCT. Patients who have undergone potentially curative surgery will be randomised to receive either simvastatin 40mg nocte or placebo on discharge from hospital for one year. Participants will be assessed at screening, baseline and at months 3, 6, 9 and 12. Assessments will include measurements of recruitment and retention, absorption, adherence, safety, quality of life, disease-free and overall survival and generalisability.
Primary outcome(s): Absorption; Timepoint(s): LDL cholesterol at 3, 6, 9 and 12 months from discharge from hospital following surgery