title: Protocol for the surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial): an RCT evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases.
abstract: BACKGROUND
  Patients with malignant pleural mesothelioma (MPM) may develop painful 'procedure tract metastasis' (PTM) at the site of previous pleural interventions. Prophylactic radiotherapy has been used to minimise this complication; however, three small randomised trials have shown conflicting results regarding its effectiveness. The surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial) is a suitably powered, multicentre, randomised controlled trial, designed to evaluate the efficacy of prophylactic radiotherapy within 42 days of pleural instrumentation in preventing the development of PTM in MPM.
  
  
  METHODS
  203 patients with a histocytologically proven diagnosis of MPM, who have undergone a large bore pleural intervention (thoracic surgery, large bore chest drain, indwelling pleural catheter or local anaesthetic thoracoscopy) in the previous 35 days, will be recruited from UK hospitals. Patients will be randomised (1:1) to receive immediate radiotherapy (21 Gy in 3 fractions over 3 working days within 42 days of the pleural intervention) or deferred radiotherapy (21 Gy in 3 fractions over 3 working days given if a PTM develops). Patients will be followed up for 12 months. The primary outcome measure is the rate of PTM until death or 12 months (whichever is sooner), as defined by the presence of a clinically palpable nodule of at least 1 cm diameter felt within 7 cm of the margins of the procedure site as confirmed by two assessors. Secondary outcome measures include chest pain, quality of life, analgaesic requirements, healthcare utilisation and safety (including radiotherapy toxicity).
  
  
  BACKGROUND
  The trial has received ethical approval from the Southampton B Research Ethics Committee (11/SC/0408). There is a Trial Steering Committee, including independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences.
  
  
  BACKGROUND
  ISRCTN72767336.
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: Amelia O
authors.identifier: http://orcid.org/0000-0001-6918-4766
authors.initials: AO
authors.lastname: Clive
authors.affiliation: University Hospitals Bristol NHS Trust, Bristol, UK.
authors.forename: Paula
authors.initials: P
authors.lastname: Wilson
authors.affiliation: Research Design Service South West, Bristol, UK.
authors.forename: Hazel
authors.initials: H
authors.lastname: Taylor
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.
authors.forename: Anna J
authors.initials: AJ
authors.lastname: Morley
authors.affiliation: Royal United Hospital, Bath, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: de Winton
authors.affiliation: Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Niki
authors.initials: N
authors.lastname: Panakis
authors.affiliation: Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Najib
authors.initials: N
authors.lastname: Rahman
authors.affiliation: Musgrove Park Hospital, Taunton, UK.
authors.forename: Justin
authors.initials: J
authors.lastname: Pepperell
authors.affiliation: Plymouth Hospitals NHS Trust, Plymouth, UK.
authors.forename: Timothy
authors.initials: T
authors.lastname: Howell
authors.affiliation: University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Timothy J P
authors.initials: TJ
authors.lastname: Batchelor
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.
authors.forename: Nikki
authors.initials: N
authors.lastname: Jordan
authors.affiliation: Centre for Asthma, Allergy and Respiratory Research, School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.
authors.forename: Y C Gary
authors.initials: YC
authors.lastname: Lee
authors.affiliation: South Devon Healthcare NHS Foundation Trust, Torbay, UK.
authors.forename: Lee
authors.initials: L
authors.lastname: Dobson
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: Nick A
authors.initials: NA
authors.lastname: Maskell
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D008654:Mesothelioma / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D000086002:Mesothelioma, Malignant; D009366:Neoplasm Seeding; D016609:Neoplasms, Second Primary / Q000517:prevention & control*; D010997:Pleural Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D018714:Radiotherapy, Adjuvant; D012107:Research Design