Clinical trial NCT01604005: PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
Official title: PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Mesothelioma
Keywords: Mesothelioma
radiotherapy
prophylactic irradiation of tracts
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2012-05-23
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.

Detailed description: Mesothelioma is a rare form of cancer affecting the protective lining that covers many of the body's internal organs. The most commonly affected areas are the lungs and internal chest wall. In the UK over 2300 patients are diagnosed with mesothelioma each year and the numbers are increasing.

As part of the diagnosis and treatment of mesothelioma, patients may undergo a procedure which involves inserting a thin tube into the chest wall enabling an internal examination and for any biopsies or samples of fluid to be taken. These procedures can result in the development of skin lumps or nodules along the tract created by inserting the tube. To try and reduce the risk of these nodules developing in the tract or at the site of the scar, radiotherapy can be given to the chest wall at the site of the tract after the procedure has been performed; this type of radiotherapy is known as prophylactic irradiation of tracts or PIT.

Although many hospitals already give patients this type of radiotherapy treatment to the chest wall we still do not know if the treatment works. This trial has been designed to answer the question about the effectiveness of PIT radiotherapy. If PIT is found to be effective in preventing or delaying the development of these skin nodules then it can be offered to all patients as part of their treatment. However, if we discover that PIT is not effective this will save patients from undergoing ineffective treatment and having to spend time making unnecessary extra visits to hospital

Eligibility criteria: Inclusion Criteria:

* Either sex, age ≥ 18 years
* Diagnosis of mesothelioma by multi-disciplinary team (MDT). All histological subtypes are eligible for the trial
* ECOG performance status 0-2 (Appendix C)
* Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT
* Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy (mini-thoracotomy), local anaesthetic thoracoscopy or chest drain
* Able to start radiotherapy within 42 days (6 weeks) of the most recent chest wall procedure
* Chest wall intervention scar visible at time of randomisation
* Radiotherapy target volume acceptable by the local radiotherapist
* Patients enrolled on other clinical trials could be considered after discussion with the chief investigators

Exclusion Criteria:

* Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)
* Previous radiotherapy to the region of the chest wall intervention site
* Indwelling pleural catheter in-situ at the intervention site
* Patients currently receiving chemotherapy

Primary outcomes:
measure: Incidence of chest wall tract metastasis 6 months from randomisation
timeFrame: 6 months
Secondary outcomes:
measure: Time from randomisation to chest wall tract metastasis
timeFrame: Weeks
measure: Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)
timeFrame: Weeks
measure: Acute and late skin radiotherapy toxicity
timeFrame: Weeks
measure: Pain from chest wall tract metastasis
timeFrame: Weeks
Other outcomes:
Locations:
city: Ashton-Under-Lyne
country: United Kingdom
facility: Tameside General Hospital
city: Basingstoke
country: United Kingdom
facility: Basingstoke & North Hampshire Hospital
city: Bebington
country: United Kingdom
facility: Clatterbridge Cancer Centre
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Blackburn
country: United Kingdom
facility: Royal Blackburn
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Burton
country: United Kingdom
facility: Queen's Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes
city: Canterbury
country: United Kingdom
facility: Kent Oncology Centre
city: Cleveland
country: United Kingdom
facility: University Hospital of North Tees
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospitals
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate District NHS Foundation Trust
city: Huddersfield
country: United Kingdom
facility: Calderdale & Hudderfield NHS Trust
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Isle Of Wight
country: United Kingdom
facility: St Mary's Hospital
city: Kidderminster
country: United Kingdom
facility: Kidderminster General Hospital
city: Lancaster
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital, Kent Oncology Centre
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: Middlesex
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Norfolk
country: United Kingdom
facility: The Queen Elizabeth hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Nottingham
country: United Kingdom
facility: Kings Mill Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Poole
country: United Kingdom
facility: Dorset Cancer Centre
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Rhyl
country: United Kingdom
facility: Glan Clwyd Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Midlands
city: Vale Of Glamorgan
country: United Kingdom
facility: Llandough Hospital
city: Walsall
country: United Kingdom
facility: Manor Hospital
city: Warwick
country: United Kingdom
facility: Warwick Hospital
city: Wigan
country: United Kingdom
facility: Wigan & Leigh NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Worcestershire
country: United Kingdom
facility: Alexandra Hospital
city: York
country: United Kingdom
facility: York Teaching Hospital
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Corinne Faivre-Finn
role: STUDY_CHAIR
affiliation: The Christie NHS Foundation Trust
name: Neil Bayman
role: STUDY_CHAIR
References:
citation: Bayman N, Appel W, Ashcroft L, Baldwin DR, Bates A, Darlison L, Edwards JG, Ezhil V, Gilligan D, Hatton M, Jegannathen A, Mansy T, Peake MD, Pemberton L, Rintoul RC, Snee M, Ryder WD, Taylor P, Faivre-Finn C. Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma: An Open-Label, Multicenter, Phase III Randomized Trial. J Clin Oncol. 2019 May 10;37(14):1200-1208. doi: 10.1200/JCO.18.01678. Epub 2019 Mar 28.
citation: Bayman N, Ardron D, Ashcroft L, Baldwin DR, Booton R, Darlison L, Edwards JG, Lang-Lazdunski L, Lester JF, Peake M, Rintoul RC, Snee M, Taylor P, Lunt C, Faivre-Finn C. 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. 2016 Jan 27;6(1):e010589. doi: 10.1136/bmjopen-2015-010589.