{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T11:24:17Z","timestamp":1765711457769,"version":"3.48.0"},"reference-count":27,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,12,7]]},"published-print":{"date-parts":[[2016,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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\u2014a 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>In this multicentre phase III randomised controlled superiority trial, 374 patients who can receive radiotherapy within 42\u2005days 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\u2005Gy in three fractions. Subsequent chemotherapy is given at the clinicians\u2019 discretion. A reduction in the incidence of chest wall nodules from 15% to 5% in favour of radiotherapy 6\u2005months after randomisation would be clinically significant. All patients will be followed up for up to 2\u2005years with monthly telephone contact and at least four outpatient visits in the first year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>PIT was approved by NRES Committee North West\u2014Greater 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\u2005months 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ISRCTN04240319;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01604005\">NCT01604005<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-010589","type":"journal-article","created":{"date-parts":[[2016,1,27]],"date-time":"2016-01-27T22:34:22Z","timestamp":1453934062000},"page":"e010589","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":24,"title":["Protocol for PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall 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Nottingham University Hospitals NHS Trust, Nottingham City Hospital Campus, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R","family":"Booton","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Darlison","sequence":"additional","affiliation":[{"name":"Mesothelioma UK Charitable Trust, c\/o Glenfield Hospital, Leicester, UK"},{"name":"Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J G","family":"Edwards","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Chesterman Unit, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust UK, Sheffield, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Lang-Lazdunski","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, The Lister Hospital, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J F","family":"Lester","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology, Velindre NHS Trust UK, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Peake","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK"},{"name":"National Cancer Intelligence Network, (NCIN), Public Health England, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R C","family":"Rintoul","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Papworth Hospital NHS 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