NCT02040272.
Trial name or title | A study to determine if it is feasible to recruit into a randomised trial comparing (extended) pleurectomy decortication versus no pleurectomy decortication in patients with malignant pleural mesothelioma |
Methods | Phase III |
Participants | Participants with histologically confirmed mesothelioma and disease confined to one hemithorax |
Interventions | Experimental arm: chemotherapy plus (Extended) pleurectomy decortication Standard arm: chemotherapy only |
Outcomes | Primary Outcome Measures 1. Ability to randomise 50 patients (TimeFrame: 24 months) 2. Ability to randomise 50 patients within the first 24 months or the ability to recruit 25 patients within any 6 month period Secondary Outcome Measures 1. Survival from the time point of randomisation (time frame: follow‐up for up to 5 years) 2. health‐related quality of life as assessed using QLQ 30 and LC‐13 scales (time frame: follow‐up for up to 5 years) |
Starting date | May 2015 |
Contact information | Eric Lim: e.lim@rbht.nhs.uk |
Notes | Sponsor: Royal Brompton & Harefield NHS Foundation Trust |