PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma (NCT01604005) | Clinical Trial Compass
TerminatedPhase 3
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
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"
United Kingdom375 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incidence of chest wall tract metastasis 6 months from randomisation