PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

Mesothelioma Clinical Trial

— PIT  

Official title:

PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01604005
• Other study ID #: 08_DOG07_93
• Secondary ID: ISRCTN04240319PB
• Status: Terminated
• Phase: Phase 3
• First received: May 21, 2012
• Last updated: January 26, 2018
• Start date: July 2012
• Est. completion date: April 5, 2017

Study information

• Verified date: January 2018
• Source: The Christie NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 375
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma

Intervention

Radiation:
• Prophylactic Irradiation of Tracts (PIT)
21 Gy in 3 fractions

Locations

Country	Name	City	State
United Kingdom	Tameside General Hospital	Ashton-Under-Lyne
United Kingdom	Basingstoke & North Hampshire Hospital	Basingstoke
United Kingdom	Clatterbridge Cancer Centre	Bebington
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	University Hospital Birmingham	Birmingham
United Kingdom	Royal Blackburn	Blackburn
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Royal Bolton Hospital	Bolton
United Kingdom	Pilgrim Hospital	Boston
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Queen's Hospital	Burton
United Kingdom	Addenbrookes	Cambridge
United Kingdom	Kent Oncology Centre	Canterbury
United Kingdom	University Hospital of North Tees	Cleveland
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Leighton Hospital	Crewe
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	The Royal Surrey County Hospital	Guildford
United Kingdom	Princess Alexandra Hospital	Harlow
United Kingdom	Harrogate District NHS Foundation Trust	Harrogate
United Kingdom	Calderdale & Hudderfield NHS Trust	Huddersfield
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	St Mary's Hospital	Isle Of Wight
United Kingdom	Kidderminster General Hospital	Kidderminster
United Kingdom	University Hospitals of Morecambe Bay NHS Foundation Trust	Lancaster
United Kingdom	St James University Hospital	Leeds
United Kingdom	University Hospital of Leicester	Leicester
United Kingdom	United Lincolnshire Hospitals	Lincoln
United Kingdom	North Middlesex Hospital	London
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Maidstone Hospital, Kent Oncology Centre	Maidstone
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	James Cook University Hospital	Middlesborough
United Kingdom	Mount Vernon Cancer Centre	Middlesex
United Kingdom	The Queen Elizabeth hospital	Norfolk
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Kings Mill Hospital	Nottingham
United Kingdom	Nottingham University Hospitals	Nottingham
United Kingdom	George Eliot Hospital	Nuneaton
United Kingdom	Royal Oldham Hospital	Oldham
United Kingdom	Peterborough City Hospital	Peterborough
United Kingdom	Dorset Cancer Centre	Poole
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Glan Clwyd Hospital	Rhyl
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Salisbury District Hospital	Salisbury
United Kingdom	Sheffield Teaching Hospital	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	University Hospital of North Midlands	Stoke-on-Trent
United Kingdom	Llandough Hospital	Vale Of Glamorgan
United Kingdom	Manor Hospital	Walsall
United Kingdom	Warwick Hospital	Warwick
United Kingdom	Wigan & Leigh NHS Foundation Trust	Wigan
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Alexandra Hospital	Worcestershire
United Kingdom	York Teaching Hospital	York

Sponsors (2)

Lead Sponsor	Collaborator
Brynn Chappell	The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chest wall tract metastasis 6 months from randomisation		6 months
Secondary	Time from randomisation to chest wall tract metastasis	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	Weeks
Secondary	Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)	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	Weeks
Secondary	Acute and late skin radiotherapy toxicity	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	Weeks
Secondary	Pain from chest wall tract metastasis	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)	Weeks

External Links

•   Christie NHS website