Clinical trial · Interventional
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention
NCT01604005CI-TRIAL-00031417PITterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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"
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Irradiation of Tracts (PIT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PIT Arm
- interventionNames
- Radiation: Prophylactic Irradiation of Tracts (PIT)
- type
- NO_INTERVENTION
- label
- No PIT Arm
Primary outcomes (1)
- measure
- Incidence of chest wall tract metastasis 6 months from randomisation
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- Time from randomisation to chest wall tract metastasis
- timeFrame
- Weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDBayman 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. PMID 30920878
- DERIVEDBayman 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. PMID 26817643