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MesotheliomaPhase 3PITNCT01604005

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

A Phase 3 study testing Prophylactic Irradiation of Tracts (PIT) in people with Mesothelioma, run by Brynn Chappell at 60 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma
What is being tested?
Prophylactic Irradiation of Tracts (PIT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
60 sitesUnited Kingdom
Study dates
Jul 2012to 5 Apr 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United Kingdom60 sites

  • Tameside General Hospital

    Ashton-under-Lyne, OL6 9RW

  • Basingstoke & North Hampshire Hospital

    Basingstoke, RG24 9NA

  • Clatterbridge Cancer Centre

    Bebington, CH63 4JY

  • Belfast City Hospital

    Belfast, BT9 7AB

  • University Hospital Birmingham

    Birmingham, B152TH

  • Royal Blackburn

    Blackburn, BB2 3HH

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • Royal Bolton Hospital

    Bolton, BL4 0JR

  • Pilgrim Hospital

    Boston, PE21 9QS

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Queen's Hospital

    Burton, DE13 0RB

  • Addenbrookes

    Cambridge, CB23 3RE

  • Kent Oncology Centre

    Canterbury, CT1 3NG

  • University Hospital of North Tees

    Cleveland, TS19 8PE

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Leighton Hospital

    Crewe, CW1 4QJ

  • Royal Derby Hospitals

    Derby, DE22 3NE

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Medway Maritime Hospital

    Gillingham, ME7 5NY

  • The Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Princess Alexandra Hospital

    Harlow, CM20 1QX

  • Harrogate District NHS Foundation Trust

    Harrogate, HG2 7SX

  • Calderdale & Hudderfield NHS Trust

    Huddersfield, HD3 3EA

  • Ipswich Hospital

    Ipswich, IP4 5PD

  • St Mary's Hospital

    Isle of Wight, PO30 5TG

  • Kidderminster General Hospital

    Kidderminster, DY11 6RJ

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    Lancaster, LA1 4RP

  • St James University Hospital

    Leeds, LS9 7TF

  • University Hospital of Leicester

    Leicester, LE1 5WW

  • United Lincolnshire Hospitals

    Lincoln, LN2 5QY

  • North Middlesex Hospital

    London, N18 1QX

  • Macclesfield District General Hospital

    Macclesfield, SK10 3BL

  • Maidstone Hospital, Kent Oncology Centre

    Maidstone, ME16 9QQ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Mount Vernon Cancer Centre

    Middlesex, HA6 2RN

  • The Queen Elizabeth hospital

    Norfolk, PE30 4ET

  • Northampton General Hospital

    Northampton, NN1 5BD

  • Kings Mill Hospital

    Nottingham, NG17 4JL

  • Nottingham University Hospitals

    Nottingham, NG5 1PB

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

  • Royal Oldham Hospital

    Oldham, OL1 2JH

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Dorset Cancer Centre

    Poole, BH15 2JB

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Glan Clwyd Hospital

    Rhyl, LL18 5UJ

  • Salford Royal Hospital

    Salford, M6 8HD

  • Salisbury District Hospital

    Salisbury, SP2 8BJ

  • Sheffield Teaching Hospital

    Sheffield, S10 2SJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • University Hospital of North Midlands

    Stoke-on-Trent, ST4 6QG

  • Llandough Hospital

    Vale of Glamorgan, CF64 2XX

  • Manor Hospital

    Walsall, WS2 9PS

  • Warwick Hospital

    Warwick, CV34 5BW

  • Wigan & Leigh NHS Foundation Trust

    Wigan, WN1 2NN

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • Alexandra Hospital

    Worcestershire, B98 7UB

  • York Teaching Hospital

    York, YO31 8HE

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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

Conditions
Mesothelioma
Being tested
Prophylactic Irradiation of Tracts (PIT)
Keywords
Mesothelioma, radiotherapy, prophylactic irradiation of tracts
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic Irradiation of Tracts (PIT)Radiation

    Also called Radiation

    21 Gy in 3 fractions

Study groups in NCT01604005
Study groupRoleWhat they receive
PIT ArmExperimentalNot described
Receives: Radiation: Prophylactic Irradiation of Tracts (PIT)
No PIT ArmNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of chest wall tract metastasis 6 months from randomisation

    Measured: 6 months

Secondary outcomes (4)

  1. 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

    Measured: Weeks

  2. 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

    Measured: Weeks

  3. 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

    Measured: Weeks

  4. 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)

    Measured: Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2012 (estimated)
  2. Study startJul 2012
  3. Primary completion5 Apr 2017
  4. Study completion5 Apr 2017

Why it 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"

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01604005
Sponsor's protocol ID
08_DOG07_93
Other IDs
ISRCTN04240319, PB-PG-1010-23232
Acronym
PIT
Status last verified
Jan 2018
First submitted
21 May 2012
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30920878

  • 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.

    PubMed 26817643

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prophylactic Irradiation of Tracts (PIT) in people with Mesothelioma, run by Brynn Chappell at 60 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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"). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of chest wall tract metastasis 6 months from randomisation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01604005, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.

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