Study 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"
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
PIT
PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention
3 other identifiers
interventional
375
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2012
Longer than P75 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2017
CompletedJanuary 29, 2018
January 1, 2018
4.8 years
May 21, 2012
January 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of chest wall tract metastasis 6 months from randomisation
6 months
Secondary Outcomes (4)
Time from randomisation to chest wall tract metastasis
Weeks
Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)
Weeks
Acute and late skin radiotherapy toxicity
Weeks
Pain from chest wall tract metastasis
Weeks
Study Arms (2)
PIT Arm
EXPERIMENTALNo PIT Arm
NO INTERVENTIONInterventions
21 Gy in 3 fractions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brynn Chappelllead
- The Christie NHS Foundation Trustcollaborator
Study Sites (60)
Tameside General Hospital
Ashton-under-Lyne, OL6 9RW, United Kingdom
Basingstoke & North Hampshire Hospital
Basingstoke, RG24 9NA, United Kingdom
Clatterbridge Cancer Centre
Bebington, CH63 4JY, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
University Hospital Birmingham
Birmingham, B152TH, United Kingdom
Royal Blackburn
Blackburn, BB2 3HH, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Royal Bolton Hospital
Bolton, BL4 0JR, United Kingdom
Pilgrim Hospital
Boston, PE21 9QS, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Queen's Hospital
Burton, DE13 0RB, United Kingdom
Addenbrookes
Cambridge, CB23 3RE, United Kingdom
Kent Oncology Centre
Canterbury, CT1 3NG, United Kingdom
University Hospital of North Tees
Cleveland, TS19 8PE, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Leighton Hospital
Crewe, CW1 4QJ, United Kingdom
Royal Derby Hospitals
Derby, DE22 3NE, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Medway Maritime Hospital
Gillingham, ME7 5NY, United Kingdom
The Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Princess Alexandra Hospital
Harlow, CM20 1QX, United Kingdom
Harrogate District NHS Foundation Trust
Harrogate, HG2 7SX, United Kingdom
Calderdale & Hudderfield NHS Trust
Huddersfield, HD3 3EA, United Kingdom
Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
St Mary's Hospital
Isle of Wight, PO30 5TG, United Kingdom
Kidderminster General Hospital
Kidderminster, DY11 6RJ, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, LA1 4RP, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
University Hospital of Leicester
Leicester, LE1 5WW, United Kingdom
United Lincolnshire Hospitals
Lincoln, LN2 5QY, United Kingdom
North Middlesex Hospital
London, N18 1QX, United Kingdom
Macclesfield District General Hospital
Macclesfield, SK10 3BL, United Kingdom
Maidstone Hospital, Kent Oncology Centre
Maidstone, ME16 9QQ, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Mount Vernon Cancer Centre
Middlesex, HA6 2RN, United Kingdom
The Queen Elizabeth hospital
Norfolk, PE30 4ET, United Kingdom
Northampton General Hospital
Northampton, NN1 5BD, United Kingdom
Kings Mill Hospital
Nottingham, NG17 4JL, United Kingdom
Nottingham University Hospitals
Nottingham, NG5 1PB, United Kingdom
George Eliot Hospital
Nuneaton, CV10 7DJ, United Kingdom
Royal Oldham Hospital
Oldham, OL1 2JH, United Kingdom
Peterborough City Hospital
Peterborough, PE3 9GZ, United Kingdom
Dorset Cancer Centre
Poole, BH15 2JB, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Glan Clwyd Hospital
Rhyl, LL18 5UJ, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Salisbury District Hospital
Salisbury, SP2 8BJ, United Kingdom
Sheffield Teaching Hospital
Sheffield, S10 2SJ, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
University Hospital of North Midlands
Stoke-on-Trent, ST4 6QG, United Kingdom
Llandough Hospital
Vale of Glamorgan, CF64 2XX, United Kingdom
Manor Hospital
Walsall, WS2 9PS, United Kingdom
Warwick Hospital
Warwick, CV34 5BW, United Kingdom
Wigan & Leigh NHS Foundation Trust
Wigan, WN1 2NN, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Alexandra Hospital
Worcestershire, B98 7UB, United Kingdom
York Teaching Hospital
York, YO31 8HE, United Kingdom
Related Publications (2)
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.
PMID: 30920878DERIVEDBayman 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.
PMID: 26817643DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Corinne Faivre-Finn
The Christie NHS Foundation Trust
- STUDY CHAIR
Neil Bayman
The Christie NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Trials Project Manager
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
July 1, 2012
Primary Completion
April 5, 2017
Study Completion
April 5, 2017
Last Updated
January 29, 2018
Record last verified: 2018-01