PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
- Conditions
- Mesothelioma
- Interventions
- Radiation: Prophylactic Irradiation of Tracts (PIT)
- Registration Number
- NCT01604005
- Lead Sponsor
- Brynn Chappell
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 375
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PIT Arm Prophylactic Irradiation of Tracts (PIT) -
- Primary Outcome Measures
Name Time Method Incidence of chest wall tract metastasis 6 months from randomisation 6 months
- Secondary Outcome Measures
Name Time Method Pain from chest wall tract metastasis Weeks Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow for pain scoring using a Visual Analogue Scale (VAS)
Time from randomisation to chest wall tract metastasis Weeks Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow up for signs of chest wall metastasis
Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field) Weeks Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow up for signs of chest wall metastasis
Acute and late skin radiotherapy toxicity Weeks Patient will attend hospital at 6, 12, 26 and 52 weeks post randomisation where toxicity to PIT will be assessed.
CTCAE v4.0 will be used
Trial Locations
- Locations (60)
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Princess Alexandra Hospital
🇬🇧Harlow, United Kingdom
University Hospital of Leicester
🇬🇧Leicester, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Kings Mill Hospital
🇬🇧Nottingham, United Kingdom
Peterborough City Hospital
🇬🇧Peterborough, United Kingdom
York Teaching Hospital
🇬🇧York, United Kingdom
Royal Blackburn
🇬🇧Blackburn, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Basingstoke & North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
University Hospital Birmingham
🇬🇧Birmingham, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, United Kingdom
Addenbrookes
🇬🇧Cambridge, United Kingdom
Leighton Hospital
🇬🇧Crewe, United Kingdom
Pilgrim Hospital
🇬🇧Boston, United Kingdom
St James University Hospital
🇬🇧Leeds, United Kingdom
Kent Oncology Centre
🇬🇧Canterbury, United Kingdom
Harrogate District NHS Foundation Trust
🇬🇧Harrogate, United Kingdom
Royal Derby Hospitals
🇬🇧Derby, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Medway Maritime Hospital
🇬🇧Gillingham, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
The Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Calderdale & Hudderfield NHS Trust
🇬🇧Huddersfield, United Kingdom
St Mary's Hospital
🇬🇧Isle Of Wight, United Kingdom
United Lincolnshire Hospitals
🇬🇧Lincoln, United Kingdom
Mount Vernon Cancer Centre
🇬🇧Middlesex, United Kingdom
The Queen Elizabeth hospital
🇬🇧Norfolk, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
🇬🇧Lancaster, United Kingdom
James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, United Kingdom
Kidderminster General Hospital
🇬🇧Kidderminster, United Kingdom
Maidstone Hospital, Kent Oncology Centre
🇬🇧Maidstone, United Kingdom
North Middlesex Hospital
🇬🇧London, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
Dorset Cancer Centre
🇬🇧Poole, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Salford Royal Hospital
🇬🇧Salford, United Kingdom
Sheffield Teaching Hospital
🇬🇧Sheffield, United Kingdom
Wigan & Leigh NHS Foundation Trust
🇬🇧Wigan, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Alexandra Hospital
🇬🇧Worcestershire, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Bebington, United Kingdom
Tameside General Hospital
🇬🇧Ashton-Under-Lyne, United Kingdom
University Hospital of North Tees
🇬🇧Cleveland, United Kingdom
Queen's Hospital
🇬🇧Burton, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Nottingham University Hospitals
🇬🇧Nottingham, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
University Hospital of North Midlands
🇬🇧Stoke-on-Trent, United Kingdom
Llandough Hospital
🇬🇧Vale Of Glamorgan, United Kingdom
Warwick Hospital
🇬🇧Warwick, United Kingdom
Manor Hospital
🇬🇧Walsall, United Kingdom