Surgical and large bore pleural procedures in malignant pleural mesothelioma and radiotherapy trial

Conditions

Topic: National Cancer Research Network, Respiratory

Samuel A. Stewart, Amelia Clive, Nick Maskell, Erika Penz

PLoS ONE2018-02-058 citations

10.1371/journal.pone.0190257

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.

Clive AO, Taylor H, Dobson L, Wilson P, de Winton E, Panakis N, Pepperell J, Howell T, Stewart SA, Penz E, Jordan N, Morley AJ, Zahan-Evans N, Smith S, Batchelor TJP, Marchbank A, Bishop L, Ionescu AA, Bayne M, Cooper S, Kerry A, Jenkins P, Toy E, Vigneswaran V, Gildersleve J, Ahmed M, McDonald F, Button M, Lewanski C, Comins C, Dakshinamoorthy M, Lee YCG, Rahman NM, Maskell NA.

2016-06-2382 citations

10.1016/s1470-2045(16)30095-x

Protocol for the surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial): an RCT evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases

Amelia Clive, Paula Wilson, Hazel Taylor, Anna J. Morley, Emma De Winton et al. (14 authors)

BMJ Open2015-01-0114 citations

10.1136/bmjopen-2014-006673

Interventions

Patients will be randomised 1:1 to receive either immediate radiotherapy (21Gy in 3 fractions over 3 days) to the pleural procedure site at trial entry, or deferred radiotherapy in the event that they

Study Entry: Single Randomisation only

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A histocytologically proven diagnosis of mesothelioma, as confirmed by a multi-disciplinary team (MDT) meeting 2. One of the following pleural interventions in the past 28 days: 2.1. Open pleural biopsy 2.2. Surgical thoracotomy or Video-assisted thoracoscopic surgery (VATS) 2.3. Local anaesthetic thoracoscopy 2.4. Large bore chest tube insertion (greater or equal to 20 Fr inserted by either a seldinger technique or blunt dissection) 2.5. Indwelling pleural catheter insertion 3. Written informed consent Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Expected survival <4 months 3. Pregnancy or lactation 4. Inability to give informed consent or comply with the protocol 5. Previous radiotherapy which would result in an unacceptable overlap with the proposed treatment field 6. The patient does not have access to a telephone 7. A clinically palpable nodule of at least 1cm diameter felt within 7cm of the margins of the procedure site at the initial trial visit

Design outcomes

Primary

Measure	Time frame
The incidence of development of PTM around the site of pleural intervention; Timepoint(s): 12 months	—

Secondary

Measure	Time frame
1. The effect of prophylactic radiotherapy on the time to PTM development.; Timepoint(s): 12 months 2. Analgesia requirements; Timepoint(s): months 1, 3, 6 ,9, 12 3. Health economics; Timepoint(s): 12 months 4. Identification of emergent themes from the semi-structured qualitative interviews; Timepoint(s): 6 months 5. Monthly chest wall pain score; Timepoint(s): monthly 6. Proportion of PTMs which are painful; Timepoint(s): 12 months 7. Self reported quality of life status; Timepoint(s): 1, 3, 6, 9, 12 months 8. The effect of chemotherapy on the development of PTM; Timepoint(s): 12 months 9. The effect of prophylactic radiotherapy on the severity of PTM when they develop; Timepoint(s): 12 months 10. The incidence of PTM in the context of indwelling pleural catheters; Timepoint(s): 12 months 11. The rate and severity of radiotherapy toxicity; Timepoint(s): 12 months	—

Measure

Time frame

1. The effect of prophylactic radiotherapy on the time to PTM development.; Timepoint(s): 12 months 2. Analgesia requirements; Timepoint(s): months 1, 3, 6 ,9, 12 3. Health economics; Timepoint(s): 12 months 4. Identification of emergent themes from the semi-structured qualitative interviews; Timepoint(s): 6 months 5. Monthly chest wall pain score; Timepoint(s): monthly 6. Proportion of PTMs which are painful; Timepoint(s): 12 months 7. Self reported quality of life status; Timepoint(s): 1, 3, 6, 9, 12 months 8. The effect of chemotherapy on the development of PTM; Timepoint(s): 12 months 9. The effect of prophylactic radiotherapy on the severity of PTM when they develop; Timepoint(s): 12 months 10. The incidence of PTM in the context of indwelling pleural catheters; Timepoint(s): 12 months 11. The rate and severity of radiotherapy toxicity; Timepoint(s): 12 months

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Countries

England, United Kingdom

Outcome results

None listed