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Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer

Lookup NU author(s): Professor Michael Griffin


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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.

Publication metadata

Author(s): Blazeby JM, Strong S, Donovan JL, Wilson C, Hollingworth W, Crosby T, Nicklin J, Falk SJ, Barham CP, Hollowood AD, Streets CG, Titcomb D, Krysztopik R, Griffin SM, Brookes ST

Publication type: Article

Publication status: Published

Journal: British Journal of Cancer

Year: 2014

Volume: 111

Issue: 2

Pages: 234-240

Print publication date: 15/07/2014

Online publication date: 12/06/2014

Acceptance date: 12/05/2014

ISSN (print): 0007-0920

ISSN (electronic): 1532-1827

Publisher: Nature Publishing Group


DOI: 10.1038/bjc.2014.313


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Funder referenceFunder name
PB-PG-0807-14131National Institute for Health Research (NIHR) under Research for Patient Benefit (RfPB) Program