title: Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  An 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.
authors.affiliation: 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.
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: 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.
authors.forename: S
authors.initials: S
authors.lastname: Strong
authors.affiliation: Centre of Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK.
authors.forename: J L
authors.initials: JL
authors.lastname: Donovan
authors.affiliation: Centre of Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK.
authors.forename: C
authors.initials: C
authors.lastname: Wilson
authors.affiliation: Centre of Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK.
authors.forename: W
authors.initials: W
authors.lastname: Hollingworth
authors.affiliation: Velindre NHS Trust, Unit 2 Charnwood Court, Cardiff CF14 2TL, UK.
authors.forename: T
authors.initials: T
authors.lastname: Crosby
authors.affiliation: Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
authors.forename: J
authors.initials: J
authors.lastname: Nicklin
authors.affiliation: Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol BS8 2PS, UK.
authors.forename: S J
authors.initials: SJ
authors.lastname: Falk
authors.affiliation: Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
authors.forename: C P
authors.initials: CP
authors.lastname: Barham
authors.affiliation: Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
authors.forename: A D
authors.initials: AD
authors.lastname: Hollowood
authors.affiliation: Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
authors.forename: C G
authors.initials: CG
authors.lastname: Streets
authors.affiliation: Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
authors.forename: D
authors.initials: D
authors.lastname: Titcomb
authors.affiliation: 1] Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK [2] Royal United Hospital Bath, Bath, BA1 3NG, UK.
authors.forename: R
authors.initials: R
authors.lastname: Krysztopik
authors.affiliation: Northern Oesophagogastric Unit, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, UK.
authors.forename: S M
authors.initials: SM
authors.lastname: Griffin
authors.affiliation: Centre of Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK.
authors.forename: S T
authors.initials: ST
authors.lastname: Brookes
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000069287:Capecitabine; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D020360:Neoadjuvant Therapy; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil