SMART
Prophylactic radiotherapy for the prevention of procedure-tract metastases after surgical and large-bore pleural procedures in malignant pleural mesothelioma (SMART): a multicentre, open-label, phase 3, randomised controlled trial
Phase 3N = 203
- Population
- Patients with histocytologically proven malignant pleural mesothelioma and a large-bore pleural intervention (open pleural biopsy, thoracotomy, video-assisted or local anaesthetic thoracoscopy, large-bore chest tube or indwelling pleural catheter) in the previous 35 days
- Design
- Multicentre, open-label, phase 3 randomised controlled trial in 22 UK hospitals (registered as ISRCTN72767336, the number the paper prints; it prints no NCT id, and a ClinicalTrials.gov search for that ISRCTN number found none). Patients with histocytologically proven mesothelioma who had a large-bore pleural intervention in the previous 35 days were randomised 1:1 (minimisation by histological subtype, surgical versus non-surgical procedure, and indwelling pleural catheter versus other) to immediate radiotherapy (21 Gy in three fractions within 42 days of the pleural intervention) or deferred radiotherapy (the same dose within 35 days of diagnosis of a procedure-tract metastasis). 203 patients were randomised between 23 December 2011 and 4 August 2014 (immediate 102, deferred 101). Primary outcome: incidence of procedure-tract metastasis within 7 cm of the intervention site within 12 months of randomisation, in the intention-to-treat population (Fisher's exact test). The predefined secondary per-protocol analysis included 183 patients.
- Primary endpoint
- Procedure-tract metastasis incidence
- Arms
- Deferred radiotherapy (control, n = 101): Radiotherapy 21 Gy in three fractions only if a procedure-tract metastasis developed (within 35 days of its diagnosis)
- Immediate radiotherapy (experimental, n = 102): Prophylactic radiotherapy 21 Gy in three fractions within 42 days of the pleural intervention
- People
- Clive AO, senior author Maskell NA
Δ Procedure-tract metastasis incidence−7 pointsΔ Procedure-tract metastasis incidence−10 points
Show the numbers
| Endpoint | Analysis | Immediate radiotherapy | Deferred radiotherapy | Effect |
|---|---|---|---|---|
| Procedure-tract metastasis incidence | primaryClive 2016 | 9% | 16% | P=0.14Within 12 months of randomisation: 9 of 102 versus 16 of 101 patients; odds ratio 0.51 (95% CI 0.19-1.32), not a hazard ratio. |
| Procedure-tract metastasis incidencePer-protocol (183 patients) | exploratoryClive 2016 | 6% | 16% | P=0.037Predefined secondary analysis excluding patients with major protocol violations: 5 of 84 versus 16 of 99; odds ratio 0.33 (95% CI 0.09-1.00). The authors point to the number of protocol deviations in immediate-radiotherapy delivery when interpreting it. |
| Endpoint | Analysis | Immediate radiotherapy | Deferred radiotherapy | Effect |
|---|---|---|---|---|
| Procedure-tract metastasis incidence | primaryClive 2016 | 9% | 16% | P=0.14Within 12 months of randomisation: 9 of 102 versus 16 of 101 patients; odds ratio 0.51 (95% CI 0.19-1.32), not a hazard ratio. |
| Procedure-tract metastasis incidencePer-protocol (183 patients) | exploratoryClive 2016 | 6% | 16% | P=0.037Predefined secondary analysis excluding patients with major protocol violations: 5 of 84 versus 16 of 99; odds ratio 0.33 (95% CI 0.09-1.00). The authors point to the number of protocol deviations in immediate-radiotherapy delivery when interpreting it. |
Appears in
Sources
Clive AO, Taylor H, Dobson L, Wilson P, de Winton E, Panakis N, et al. Prophylactic radiotherapy for the prevention of procedure-tract metastases after surgical and large-bore pleural procedures in malignant pleural mesothelioma (SMART): a multicentre, open-label, phase 3, randomised controlled trial. Lancet Oncol. 2016;17(8):1094-1104.