Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01604005
Recruitment Status : Terminated (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")
First Posted : May 23, 2012
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
Brynn Chappell, The Christie NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Mesothelioma Radiation: Prophylactic Irradiation of Tracts (PIT) Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : July 2012
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: PIT Arm Radiation: Prophylactic Irradiation of Tracts (PIT)
21 Gy in 3 fractions
Other Name: Radiation

No Intervention: No PIT Arm



Primary Outcome Measures :
  1. Incidence of chest wall tract metastasis 6 months from randomisation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


  4. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604005


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Brynn Chappell, Clinical Trials Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01604005     History of Changes
Other Study ID Numbers: 08_DOG07_93
ISRCTN04240319 ( Registry Identifier: ISRCTN )
PB-PG-1010-23232 ( Other Grant/Funding Number: NIHR Research for Patient Benefit )
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Brynn Chappell, The Christie NHS Foundation Trust:
Mesothelioma
radiotherapy
prophylactic irradiation of tracts

Additional relevant MeSH terms:
Layout table for MeSH terms
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial