title: Protocol for PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention.
abstract: BACKGROUND
  Histological diagnosis of malignant mesothelioma requires an invasive procedure such as CT-guided needle biopsy, thoracoscopy, video-assisted thorascopic surgery (VATs) or thoracotomy. These invasive procedures encourage tumour cell seeding at the intervention site and patients can develop tumour nodules within the chest wall. In an effort to prevent nodules developing, it has been widespread practice across Europe to irradiate intervention sites postprocedure--a practice known as prophylactic irradiation of tracts (PIT). To date there has not been a suitably powered randomised trial to determine whether PIT is effective at reducing the risk of chest wall nodule development.
  
  
  METHODS
  In this multicentre phase III randomised controlled superiority trial, 374 patients who can receive radiotherapy within 42 days of a chest wall intervention will be randomised to receive PIT or no PIT. Patients will be randomised on a 1:1 basis. Radiotherapy in the PIT arm will be 21 Gy in three fractions. Subsequent chemotherapy is given at the clinicians' discretion. A reduction in the incidence of chest wall nodules from 15% to 5% in favour of radiotherapy 6 months after randomisation would be clinically significant. All patients will be followed up for up to 2 years with monthly telephone contact and at least four outpatient visits in the first year.
  
  
  BACKGROUND
  PIT was approved by NRES Committee North West-Greater Manchester West (REC reference 12/NW/0249) and recruitment is currently on-going, the last patient is expected to be randomised by the end of 2015. The analysis of the primary end point, incidence of chest wall nodules 6 months after randomisation, is expected to be published in 2016 in a peer reviewed journal and results will also be presented at scientific meetings and summary results published online. A follow-up analysis is expected to be published in 2018.
  
  
  BACKGROUND
  ISRCTN04240319; NCT01604005; Pre-results.
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: N
authors.initials: N
authors.lastname: Bayman
authors.affiliation: The National Cancer Research Institute (NCRI) Consumer Liaison Group, London, UK.
authors.forename: D
authors.initials: D
authors.lastname: Ardron
authors.affiliation: Manchester Academic Health Science Centre Trials Co-ordination Unit (MAHSC-CTU), The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: L
authors.initials: L
authors.lastname: Ashcroft
authors.affiliation: Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals NHS Trust, Nottingham City Hospital Campus, Nottingham, UK.
authors.forename: D R
authors.initials: DR
authors.lastname: Baldwin
authors.affiliation: Respiratory and Allergy Research Group, Institute of Inflammation & Repair, The University of Manchester North West Lung Centre, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.
authors.forename: R
authors.initials: R
authors.lastname: Booton
authors.affiliation: Mesothelioma UK Charitable Trust, c/o Glenfield Hospital, Leicester, UK Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.
authors.forename: L
authors.initials: L
authors.lastname: Darlison
authors.affiliation: Department of Cardiothoracic Surgery, Chesterman Unit, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust UK, Sheffield, UK.
authors.forename: J G
authors.initials: JG
authors.lastname: Edwards
authors.affiliation: Department of Thoracic Surgery, The Lister Hospital, London, UK.
authors.forename: L
authors.initials: L
authors.lastname: Lang-Lazdunski
authors.affiliation: Department of Clinical Oncology, Velindre NHS Trust UK, Cardiff, UK.
authors.forename: J F
authors.initials: JF
authors.lastname: Lester
authors.affiliation: Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK National Cancer Intelligence Network, (NCIN), Public Health England, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Peake
authors.affiliation: Department of Thoracic Oncology, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: R C
authors.initials: RC
authors.lastname: Rintoul
authors.affiliation: Department of Clinical Oncology, Leeds Teaching Hospital NHS Trust, St James Hospital, Leeds, UK.
authors.forename: M
authors.initials: M
authors.lastname: Snee
authors.affiliation: Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK Department Pulmonary Oncology, Wythenshawe Hospital Manchester, Manchester, UK.
authors.forename: P
authors.initials: P
authors.lastname: Taylor
authors.affiliation: Manchester Academic Health Science Centre Trials Co-ordination Unit (MAHSC-CTU), The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: C
authors.initials: C
authors.lastname: Lunt
authors.affiliation: The University of Manchester, Manchester Academic Health Science Centre, Institute of Cancer Sciences, Manchester Cancer Research Centre (MCRC), Manchester, UK Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: C
authors.identifier: http://orcid.org/0000-0001-5617-9781
authors.initials: C
authors.lastname: Faivre-Finn
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000517:prevention & control* / Q000532:radiotherapy / Q000601:surgery; D008297:Male; D008654:Mesothelioma / Q000517:prevention & control* / Q000532:radiotherapy / Q000601:surgery; D000086002:Mesothelioma, Malignant; D009366:Neoplasm Seeding; D018579:Patient Selection; D010997:Pleural Neoplasms / Q000517:prevention & control* / Q000532:radiotherapy / Q000601:surgery; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control*; D018714:Radiotherapy, Adjuvant; D013899:Thoracic Neoplasms / Q000517:prevention & control / Q000556:secondary; D035441:Thoracic Wall; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents
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