Lung Cancer, Mesothelioma Cancer Mesothelioma of pleura
Conditions
Interventions
Patients who meet the eligibility criteria will be randomised to PIT or No PIT. The PIT patients will receive radiotherapy at 21 Gy in 3 fractions to the intervention (surgery) site. Chemotherapy on
Sponsors
Christie Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Either sex, age = 18 year 2. Diagnosis of mesothelioma by MDT 3. All histological subtypes. Where the histological diagnosis is unclear, a specialist thoracic pathologist should be consulted. 4. ECOG performance status 0-2. 5. Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT. 6. Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy, local anaesthetic thoracoscopy or chest drain. 7. Able to start radiotherapy within 42 days (6 weeks) from most recent chest wall intervention. 8. Chest wall intervention scar visible at time of randomisation. 9. No indwelling pleural catheters in-situ at the intervention site 10. RT target volume acceptable by the local radiotherapist. 11. No previous open thoracotomy. 12. No previous radiotherapy to the region of the chest wall intervention site. 13. Not currently receiving chemotherapy and not received chemotherapy for mesothelioma before randomisation 14. No other previous or concomitant illness or treatment which in the opinion of the clinician will interfere with the trial treatments or comparisons. 15. Patients enrolled on other clinical trials could be considered after discussion with the chief investigators. 16. Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. 17. Patients must not be breastfeeding 18. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 19. Before patient registration/randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations. 20. Patients can only be randomised in this trial once.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique) 2. Previous radiotherapy to the region of the chest wall intervention site 3. Patients currently receiving chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy as assessed by the incidence of chest wall metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity of PIT 2. Time to chest wall metastasis in patients undergoing PIT as compared to no radiotherapy 3. Pain from chest wall metastasis | — |
Countries
United Kingdom
Outcome results
None listed