PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
Conditions
Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
Mesothelioma, radiotherapy, prophylactic irradiation of tracts
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Prophylactic Irradiation of Tracts (PIT)
Type: Radiation
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Tameside General Hospital
Ashton-Under-Lyne, United Kingdom
Status: Recruiting
Basingstoke & North Hampshire Hospital
Basingstoke, United Kingdom
Status: Recruiting
Clatterbridge Cancer Centre
Bebington, United Kingdom
Status: Recruiting
Belfast City Hospital
Belfast, United Kingdom
Status: Recruiting
University Hospital Birmingham
Birmingham, United Kingdom
Status: Recruiting
Royal Blackburn
Blackburn, United Kingdom
Status: Recruiting
Blackpool Victoria Hospital
Blackpool, United Kingdom
Status: Recruiting
Royal Bolton Hospital
Bolton, United Kingdom
Status: Recruiting
Pilgrim Hospital
Boston, United Kingdom
Status: Recruiting
Bradford Royal Infirmary
Bradford, United Kingdom
Status: Recruiting
Queen's Hospital
Burton, United Kingdom
Status: Recruiting
Addenbrookes
Cambridge, United Kingdom
Status: Recruiting
Kent Oncology Centre
Canterbury, United Kingdom
Status: Recruiting
University Hospital of North Tees
Cleveland, United Kingdom
Status: Recruiting
University Hospital Coventry
Coventry, United Kingdom
Status: Recruiting
Leighton Hospital
Crewe, United Kingdom
Status: Recruiting
Royal Derby Hospitals
Derby, United Kingdom
Status: Recruiting
Ninewells Hospital
Dundee, United Kingdom
Status: Recruiting
Western General Hospital
Edinburgh, United Kingdom
Status: Recruiting
Medway Maritime Hospital
Gillingham, United Kingdom
Status: Recruiting
The Royal Surrey County Hospital
Guildford, United Kingdom
Status: Recruiting
Princess Alexandra Hospital
Harlow, United Kingdom
Status: Recruiting
Harrogate District NHS Foundation Trust
Harrogate, United Kingdom
Status: Recruiting
Calderdale & Hudderfield NHS Trust
Huddersfield, United Kingdom
Status: Recruiting
Ipswich Hospital
Ipswich, United Kingdom
Status: Recruiting
St Mary's Hospital
Isle of Wight, United Kingdom
Status: Recruiting
Kidderminster General Hospital
Kidderminster, United Kingdom
Status: Recruiting
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, United Kingdom
Status: Recruiting
St James University Hospital
Leeds, United Kingdom
Status: Recruiting
University Hospital of Leicester
Leicester, United Kingdom
Status: Recruiting
United Lincolnshire Hospitals
Lincoln, United Kingdom
Status: Recruiting
North Middlesex Hospital
London, United Kingdom
Status: Recruiting
Macclesfield District General Hospital
Macclesfield, United Kingdom
Status: Recruiting
Maidstone Hospital, Kent Oncology Centre
Maidstone, United Kingdom
Status: Recruiting
The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Recruiting
Wythenshawe Hospital
Manchester, United Kingdom
Status: Recruiting
James Cook University Hospital
Middlesborough, United Kingdom
Status: Recruiting
Mount Vernon Cancer Centre
Middlesex, United Kingdom
Status: Recruiting
The Queen Elizabeth hospital
Norfolk, United Kingdom
Status: Recruiting
Northampton General Hospital
Northampton, United Kingdom
Status: Recruiting
Kings Mill Hospital
Nottingham, United Kingdom
Status: Recruiting
Nottingham University Hospitals
Nottingham, United Kingdom
Status: Recruiting
George Eliot Hospital
Nuneaton, United Kingdom
Status: Recruiting
Royal Oldham Hospital
Oldham, United Kingdom
Status: Recruiting
Peterborough City Hospital
Peterborough, United Kingdom
Status: Recruiting
Dorset Cancer Centre
Poole, United Kingdom
Status: Recruiting
Royal Preston Hospital
Preston, United Kingdom
Status: Recruiting
Glan Clwyd Hospital
Rhyl, United Kingdom
Status: Recruiting
Salford Royal Hospital
Salford, United Kingdom
Status: Recruiting
Salisbury District Hospital
Salisbury, United Kingdom
Status: Recruiting
Sheffield Teaching Hospital
Sheffield, United Kingdom
Status: Recruiting
Southampton General Hospital
Southampton, United Kingdom
Status: Recruiting
University Hospital of North Midlands
Stoke-on-Trent, United Kingdom
Status: Recruiting
Llandough Hospital
Vale of Glamorgan, United Kingdom
Status: Recruiting
Manor Hospital
Walsall, United Kingdom
Status: Recruiting
Warwick Hospital
Warwick, United Kingdom
Status: Recruiting
Wigan & Leigh NHS Foundation Trust
Wigan, United Kingdom
Status: Recruiting
New Cross Hospital
Wolverhampton, United Kingdom
Status: Recruiting
Alexandra Hospital
Worcestershire, United Kingdom
Status: Recruiting
York Teaching Hospital
York, United Kingdom
Status: Recruiting
Start Date
July 2012
Completion Date
August 2017
Sponsors
Colin Lunt
Source
Christie Hospital NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page