search
Back to results

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

Primary Purpose

Mesothelioma

Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Prophylactic Irradiation of Tracts (PIT)
Sponsored by
Brynn Chappell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mesothelioma focused on measuring Mesothelioma, radiotherapy, prophylactic irradiation of tracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tameside General Hospital
  • Basingstoke & North Hampshire Hospital
  • Clatterbridge Cancer Centre
  • Belfast City Hospital
  • University Hospital Birmingham
  • Royal Blackburn
  • Blackpool Victoria Hospital
  • Royal Bolton Hospital
  • Pilgrim Hospital
  • Bradford Royal Infirmary
  • Queen's Hospital
  • Addenbrookes
  • Kent Oncology Centre
  • University Hospital of North Tees
  • University Hospital Coventry
  • Leighton Hospital
  • Royal Derby Hospitals
  • Ninewells Hospital
  • Western General Hospital
  • Medway Maritime Hospital
  • The Royal Surrey County Hospital
  • Princess Alexandra Hospital
  • Harrogate District NHS Foundation Trust
  • Calderdale & Hudderfield NHS Trust
  • Ipswich Hospital
  • St Mary's Hospital
  • Kidderminster General Hospital
  • University Hospitals of Morecambe Bay NHS Foundation Trust
  • St James University Hospital
  • University Hospital of Leicester
  • United Lincolnshire Hospitals
  • North Middlesex Hospital
  • Macclesfield District General Hospital
  • Maidstone Hospital, Kent Oncology Centre
  • The Christie NHS Foundation Trust
  • Wythenshawe Hospital
  • James Cook University Hospital
  • Mount Vernon Cancer Centre
  • The Queen Elizabeth hospital
  • Northampton General Hospital
  • Kings Mill Hospital
  • Nottingham University Hospitals
  • George Eliot Hospital
  • Royal Oldham Hospital
  • Peterborough City Hospital
  • Dorset Cancer Centre
  • Royal Preston Hospital
  • Glan Clwyd Hospital
  • Salford Royal Hospital
  • Salisbury District Hospital
  • Sheffield Teaching Hospital
  • Southampton General Hospital
  • University Hospital of North Midlands
  • Llandough Hospital
  • Manor Hospital
  • Warwick Hospital
  • Wigan & Leigh NHS Foundation Trust
  • New Cross Hospital
  • Alexandra Hospital
  • York Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PIT Arm

No PIT Arm

Arm Description

Outcomes

Primary Outcome Measures

Incidence of chest wall tract metastasis 6 months from randomisation

Secondary Outcome Measures

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
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
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
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)

Full Information

First Posted
May 21, 2012
Last Updated
January 26, 2018
Sponsor
Brynn Chappell
Collaborators
The Christie NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01604005
Brief Title
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
CI Decision:That once the last patient has reached 1 year follow-up, no further follow up needs to be completed on patients recruited in PIT"
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brynn Chappell
Collaborators
The Christie NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
Mesothelioma, radiotherapy, prophylactic irradiation of tracts

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIT Arm
Arm Type
Experimental
Arm Title
No PIT Arm
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Irradiation of Tracts (PIT)
Other Intervention Name(s)
Radiation
Intervention Description
21 Gy in 3 fractions
Primary Outcome Measure Information:
Title
Incidence of chest wall tract metastasis 6 months from randomisation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time from randomisation to chest wall tract metastasis
Description
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
Time Frame
Weeks
Title
Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)
Description
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
Time Frame
Weeks
Title
Acute and late skin radiotherapy toxicity
Description
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
Time Frame
Weeks
Title
Pain from chest wall tract metastasis
Description
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 Frame
Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Faivre-Finn
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neil Bayman
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Tameside General Hospital
City
Ashton-Under-Lyne
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Facility Name
Basingstoke & North Hampshire Hospital
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
University Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B152TH
Country
United Kingdom
Facility Name
Royal Blackburn
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Pilgrim Hospital
City
Boston
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Queen's Hospital
City
Burton
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
Facility Name
Addenbrookes
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Kent Oncology Centre
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
University Hospital of North Tees
City
Cleveland
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Leighton Hospital
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Royal Derby Hospitals
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
The Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Princess Alexandra Hospital
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Harrogate District NHS Foundation Trust
City
Harrogate
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Calderdale & Hudderfield NHS Trust
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
St Mary's Hospital
City
Isle Of Wight
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
Facility Name
Kidderminster General Hospital
City
Kidderminster
ZIP/Postal Code
DY11 6RJ
Country
United Kingdom
Facility Name
University Hospitals of Morecambe Bay NHS Foundation Trust
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospital of Leicester
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
United Lincolnshire Hospitals
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
North Middlesex Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
ZIP/Postal Code
SK10 3BL
Country
United Kingdom
Facility Name
Maidstone Hospital, Kent Oncology Centre
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
The Queen Elizabeth hospital
City
Norfolk
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Kings Mill Hospital
City
Nottingham
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
George Eliot Hospital
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Royal Oldham Hospital
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Peterborough City Hospital
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Sheffield Teaching Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospital of North Midlands
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Llandough Hospital
City
Vale Of Glamorgan
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Manor Hospital
City
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Warwick Hospital
City
Warwick
ZIP/Postal Code
CV34 5BW
Country
United Kingdom
Facility Name
Wigan & Leigh NHS Foundation Trust
City
Wigan
ZIP/Postal Code
WN1 2NN
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Alexandra Hospital
City
Worcestershire
ZIP/Postal Code
B98 7UB
Country
United Kingdom
Facility Name
York Teaching Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30920878
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.
Results Reference
derived
PubMed Identifier
26817643
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.
Results Reference
derived
Links:
URL
http://www.christie.nhs.uk/
Description
Christie NHS website

Learn more about this trial

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

We'll reach out to this number within 24 hrs