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
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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Incidence of chest wall tract metastasis 6 months from randomisation
6 months
No
Corinne Faivre-Finn
Study Chair
The Christie NHS Foundation Trust
United Kingdom: Research Ethics Committee
08_DOG07_93
NCT01604005
July 2012
August 2017
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