• J M Blazeby, S Strong, J L Donovan, C Wilson, W Hollingworth, T Crosby, J Nicklin, S J Falk, C P Barham, A D Hollowood, C G Streets, D Titcomb, R Krysztopik, S M Griffin, and S T Brookes.
• 1] Centre of Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK [2] Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
• Br. J. Cancer. 2014 Jul 15;111(2):234-40.

BackgroundThe optimal treatment for localised oesophageal squamous cell carcinoma (SCC) is uncertain. We assessed the feasibility of an RCT comparing neoadjuvant treatment and surgery with definitive chemoradiotherapy.MethodsA feasibility RCT in three centres examined incident patients and reasons for ineligibility using multi-disciplinary team meeting records. Eligible patients were offered participation in the RCT with integrated qualitative research involving audio-recorded recruitment appointments and interviews with patients to inform recruitment training for staff.ResultsOf 375 patients with oesophageal SCC, 42 (11.2%) were eligible. Reasons for eligibility varied between centres, with significantly differing proportions of patients excluded because of total tumour length (P=0.002). Analyses of audio-recordings and patient interviews showed that recruiters had challenges articulating the trial design in simple terms, balancing treatment arms and explaining the need for randomisation. Before analyses of the qualitative data and recruiter training no patients were randomised. Following training in one centre 5 of 16 eligible patients were randomised.ConclusionsAn RCT of surgical vs non-surgical treatment for SCC of the oesophagus is not feasible in the UK alone because of the low number of incident eligible patients. A trial comparing diverse treatment approaches may be possible with investment to support the recruitment process.

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