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

January 26, 2018 updated by: Brynn Chappell

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ashton-Under-Lyne, United Kingdom, OL6 9RW
        • Tameside General Hospital
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke & North Hampshire Hospital
      • Bebington, United Kingdom, CH63 4JY
        • Clatterbridge Cancer Centre
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Birmingham, United Kingdom, B152TH
        • University Hospital Birmingham
      • Blackburn, United Kingdom, BB2 3HH
        • Royal Blackburn
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bolton, United Kingdom, BL4 0JR
        • Royal Bolton Hospital
      • Boston, United Kingdom, PE21 9QS
        • Pilgrim Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Burton, United Kingdom, DE13 0RB
        • Queen's Hospital
      • Cambridge, United Kingdom, CB23 3RE
        • Addenbrookes
      • Canterbury, United Kingdom, CT1 3NG
        • Kent Oncology Centre
      • Cleveland, United Kingdom, TS19 8PE
        • University Hospital of North Tees
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Crewe, United Kingdom, CW1 4QJ
        • Leighton Hospital
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospitals
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Gillingham, United Kingdom, ME7 5NY
        • Medway Maritime Hospital
      • Guildford, United Kingdom, GU2 7XX
        • The Royal Surrey County Hospital
      • Harlow, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital
      • Harrogate, United Kingdom, HG2 7SX
        • Harrogate District NHS Foundation Trust
      • Huddersfield, United Kingdom, HD3 3EA
        • Calderdale & Hudderfield NHS Trust
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Isle Of Wight, United Kingdom, PO30 5TG
        • St Mary's Hospital
      • Kidderminster, United Kingdom, DY11 6RJ
        • Kidderminster General Hospital
      • Lancaster, United Kingdom, LA1 4RP
        • University Hospitals of Morecambe Bay NHS Foundation Trust
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Leicester, United Kingdom, LE1 5WW
        • University Hospital of Leicester
      • Lincoln, United Kingdom, LN2 5QY
        • United Lincolnshire Hospitals
      • London, United Kingdom, N18 1QX
        • North Middlesex Hospital
      • Macclesfield, United Kingdom, SK10 3BL
        • Macclesfield District General Hospital
      • Maidstone, United Kingdom, ME16 9QQ
        • Maidstone Hospital, Kent Oncology Centre
      • Manchester, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Trust
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Middlesborough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
      • Norfolk, United Kingdom, PE30 4ET
        • The Queen Elizabeth Hospital
      • Northampton, United Kingdom, NN1 5BD
        • Northampton General Hospital
      • Nottingham, United Kingdom, NG17 4JL
        • Kings Mill Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals
      • Nuneaton, United Kingdom, CV10 7DJ
        • George Eliot Hospital
      • Oldham, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
      • Poole, United Kingdom, BH15 2JB
        • Dorset Cancer Centre
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Rhyl, United Kingdom, LL18 5UJ
        • Glan Clwyd Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Sheffield Teaching Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • University Hospital of North Midlands
      • Vale Of Glamorgan, United Kingdom, CF64 2XX
        • LLandough Hospital
      • Walsall, United Kingdom, WS2 9PS
        • Manor Hospital
      • Warwick, United Kingdom, CV34 5BW
        • Warwick Hospital
      • Wigan, United Kingdom, WN1 2NN
        • Wigan & Leigh NHS Foundation Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worcestershire, United Kingdom, B98 7UB
        • Alexandra Hospital
      • York, United Kingdom, YO31 8HE
        • York Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIT Arm
Radiation: Prophylactic Irradiation of Tracts (PIT)
21 Gy in 3 fractions
Other Names:
  • Radiation
No Intervention: No PIT Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of chest wall tract metastasis 6 months from randomisation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomisation to chest wall tract metastasis
Time Frame: 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
Weeks
Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)
Time Frame: 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
Weeks
Acute and late skin radiotherapy toxicity
Time Frame: 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
Weeks
Pain from chest wall tract metastasis
Time Frame: 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)
Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brynn Chappell

Collaborators

The Christie NHS Foundation Trust

Investigators

  • Study Chair: Corinne Faivre-Finn, The Christie Nhs Foundation Trust
  • Study Chair: Neil Bayman, The Christie Nhs Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

April 5, 2017

Study Completion (Actual)

April 5, 2017

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08_DOG07_93
  • ISRCTN04240319 (Registry Identifier: ISRCTN)
  • PB-PG-1010-23232 (Other Grant/Funding Number: NIHR Research for Patient Benefit)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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