The STAT-ROC Feasibility Study (v1.0)
Research type
Research Study
Full title
A feasibility study of adjuvant STATin therapy in the prevention of post-operative Recurrence of Oesophageal adenoCarcinoma (The STAT-ROC feasibility study)
IRAS ID
135174
Contact name
Andrew Hart
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eudract number
2014-001318-24
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Patients with cancer of the gullet, oesophageal adenocarcinoma (OAC), generally have a very poor prognosis. Most patients cannot be cured, have a poor quality of life, and die very quickly. Even in up to half of patients who have potentially curative surgery and chemotherapy, by one year the cancer comes back. Effective new treatments to prolong survival and improve quality of life in this patient group need to be investigated. One possibility are statins, medications that are used commonly to prevent and treat heart disease and are well tolerated by most patients. Laboratory experiments suggest that statins either kill or reduce the rate of growth of OAC cells. Our observational research suggests that patients with OAC who take statins live significantly longer than those who do not. Before statins can be recommended for use in the treatment of OAC, randomised controlled trials are required to prove their effect. Before such a clinical trial can be undertaken important information is needed to inform its justification and design. We propose a feasibility study in 36 patients who have had a potentially curative operation for OAC. Patients will be prescribed either simvastatin 40mg or a placebo (dummy pill) to take daily for one year. Patients will be allocated in equal numbers at random to one of these medications and will be unaware of which treatment they will receive, as will the researchers. Patients will have blood tests and complete questionnaires at 3 monthly intervals. We aim to determine: the recruitment and retention rate for the study; whether statins are adequately absorbed; whether participants are willing to take the medication; the side-effects experienced; whether the drugs affect quality of life; whether there is early evidence they affect survival; and how generalisable the study is to the treated UK population.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/0247
Date of REC Opinion
1 Jul 2014
REC opinion
Further Information Favourable Opinion