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

Phase 3
18 Years
Open (Enrolling)

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Trial Information

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

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

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of chest wall tract metastasis 6 months from randomisation

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Corinne Faivre-Finn

Investigator Role:

Study Chair

Investigator Affiliation:

The Christie NHS Foundation Trust


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

July 2012

Completion Date:

August 2017

Related Keywords:

  • Mesothelioma
  • Mesothelioma
  • radiotherapy
  • prophylactic irradiation of tracts
  • Mesothelioma