title: Protocol for a multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer (SAILOR).
abstract: There are 11 500 rectal cancers diagnosed annually in the UK. Although surgery remains the primary treatment, there is evidence that preoperative radiotherapy (RT) improves local recurrence rates. High-quality surgery in rectal cancer is equally important in minimising local recurrence. Advances in MRI-guided prediction of resection margin status and improvements in abdominoperineal excision of the rectum (APER) technique supports a reassessment of the contribution of preoperative RT. A more selective approach to RT may be appropriate given the associated toxicity.
  
  
  
  This trial will explore the feasibility of a definitive trial evaluating the omission of RT in resectable low rectal cancer requiring APER. It will test the feasibility of randomising patients to (1) standard care (neoadjuvant long course RT±chemotherapy and APER, or (2) APER surgery alone for cT2/T3ab N0/1 low rectal cancer with clear predicted resection margins on MRI. RT schedule will be 45 Gy over 5 weeks as current standard, with restaging and surgery after 8-12 weeks. Recruitment will be for 24 months with a minimum 12-month follow-up.
  
  
  
  Objectives include testing the ability to recruit, consent and retain patients, to quantify the number of patients eligible for a definitive trial and to test feasibility of outcomes measures. These include locoregional recurrence rates, distance to circumferential resection margin, toxicity and surgical complications including perineal wound healing, quality of life and economic analysis. The quality of MRI staging, RT delivery and surgical specimen quality will be closely monitored.
  
  
  
  The trial is approved by the Regional Ethics Committee and Health Research Authority (HRA) or equivalent. Written informed consent will be obtained. Serious adverse events will be reported to Swansea Trials Unit (STU), the ethics committee and trial sites. Trial results will be submitted for peer review publication and to trial participants.
  
  
  
  ISRCTN02406823.
authors.affiliation: Department of Colorectal Surgery, Singleton Hospital, Swansea, UK.
authors.forename: Dean A
authors.identifier: 0000-0003-2673-8946
authors.initials: DA
authors.lastname: Harris
authors.affiliation: Swansea Trials Unit, Swansea University, Swansea, UK.
authors.forename: Kymberley
authors.initials: K
authors.lastname: Thorne
authors.affiliation: Swansea Trials Unit, Swansea University, Swansea, UK.
authors.forename: Hayley
authors.initials: H
authors.lastname: Hutchings
authors.affiliation: Swansea Trials Unit, Swansea University, Swansea, UK.
authors.forename: Saiful
authors.initials: S
authors.lastname: Islam
authors.affiliation: Swansea Trials Unit, Swansea University, Swansea, UK.
authors.forename: Gail
authors.initials: G
authors.lastname: Holland
authors.affiliation: South West Wales Cancer Centre, Singleton Hospital, Swansea, UK.
authors.forename: Olivia
authors.initials: O
authors.lastname: Hatcher
authors.affiliation: South West Wales Cancer Centre, Singleton Hospital, Swansea, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Gwynne
authors.affiliation: Department of Colorectal Surgery, St Marks Hospital, London, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Jenkins
authors.affiliation: Department of Colorectal Surgery, Royal Victoria Infirmary, Newcastle, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Coyne
authors.affiliation: Department of Colorectal Surgery, Western General Hospital, Edinburgh, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Duff
authors.affiliation: Department of Colorectal Surgery, Royal Cornwall Hospital, Truro, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Feldman
authors.affiliation: Department of Colorectal Surgery, St Vincent's Hospital, Dublin, Ireland.
authors.forename: Des C
authors.initials: DC
authors.lastname: Winter
authors.affiliation: Department of Oncology, North Wales Cancer Treatment Centre, Rhyl, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Gollins
authors.affiliation: Pathology and Tumour Biology, Leeds Institute of Oncology and Pathology, Wellcome Trust Brenner Building, St James Hospital, Leeds, UK.
authors.forename: Phil
authors.initials: P
authors.lastname: Quirke
authors.affiliation: Pathology and Tumour Biology, Leeds Institute of Oncology and Pathology, Wellcome Trust Brenner Building, St James Hospital, Leeds, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: West
authors.affiliation: Department of Radiology, Royal Marsden Hospital, London, UK.
authors.forename: Gina
authors.initials: G
authors.lastname: Brown
authors.affiliation: Swansea Centre for Health Economics, Swansea University, Swansea, UK.
authors.forename: Deborah
authors.initials: D
authors.lastname: Fitzsimmons
authors.affiliation: Involving People Network, Health and Care Research Wales.
authors.forename: Alan
authors.initials: A
authors.lastname: Brown
authors.affiliation: Department of Colorectal Surgery, Singleton Hospital, Swansea, UK.
authors.forename: John
authors.initials: J
authors.lastname: Beynon
mesh_terms: D000328:Adult; D000368:Aged; D013505:Digestive System Surgical Procedures; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D000072662:Margins of Excision; D008875:Middle Aged; D008889:Military Personnel; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000601:surgery; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects*; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D006113:United Kingdom