Protocol for PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention

BMJ Open
Neil BaymanCorinne Faivre-Finn

Abstract

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. 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 ...Continue Reading

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Jun 28, 2016·The Lancet Oncology·Giovanni Luca Ceresoli, Vittorio Vavassori
Oct 14, 2016·The Lancet Oncology·Amelia O CliveNick A Maskell
Apr 21, 2017·Current Opinion in Pulmonary Medicine·David T Arnold, Amelia O Clive
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Methods Mentioned

BETA
biopsy
irradiate
prophylactic irradiation
contraception

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