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

ISRCTN	ISRCTN72767336
DOI	https://doi.org/10.1186/ISRCTN72767336
Secondary identifying numbers	11023

Submission date: 28/10/2011
Registration date: 28/10/2011
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-radiotherapy-prevent-spread-mesothelioma-after-chest-wall-operation-smart-trial

Contact information

Dr Amelia Dunscombe
Scientific

Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Email	Amelia.Dunscombe@nbt.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Prevention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Surgical and large bore pleural procedures in malignant pleural Mesothelioma And Radiotherapy Trial (SMART trial): a randomised controlled trial evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases
Study acronym	SMART
Study objectives	Malignant pleural mesothelioma (MPM) is a fatal primary tumour of the pleura and the UK incidence continues to rise. Patients often undergo multiple pleural procedures in order to obtain a diagnosis. Unfortunately there is a risk of tumour seeding along the procedure tracts and subsequent development of painful tract metastases, which can be very difficult to treat. Prophylactic radiotherapy has been used for many years with a view to preventing procedure tract metastases, however the results of recent research have questioned its benefit. Prophylactic radiotherapy involves several hospital attendances for patients at a time soon after their diagnosis, which can impact negatively on the patients quality of life at this difficult time. Recent evidence suggests that the patients at highest risk of developing procedure tract metastases (PTM) are those who have undergone larger thoracic incisions, such as surgical procedures or large bore chest drain insertions. This randomised controlled trial endeavours to identify the optimal timing of chest wall radiotherapy in this patient group and examine its effectiveness. This robust multicentre study will randomise 203 patients with confirmed MPM who have undergone a large bore thoracic procedure to receive immediate (prophylactic) radiotherapy or deferred radiotherapy should they develop a PTM. Patients will be carefully followed up for the development of PTM and quality of life measures and pain scores will be evaluated. By so doing, we hope to answer the heavily debated question about the role and optimal timing of prophylactic radiotherapy in malignant pleural mesothelioma.
Ethics approval(s)	NRES Committee South Central- Southampton B, First MREC approval date 21/09/2011, ref:11/SC/0408
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network, Respiratory; Subtopic: Lung Cancer, Respiratory (all Subtopics); Disease: Mesothelioma, Respiratory
Intervention	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 develop a procedure tract metastasis. Follow Up Length: 12 month(s); Study Entry: Single Randomisation only
Intervention type	Other
Primary outcome measure	The incidence of development of PTM around the site of pleural intervention; Timepoint(s): 12 months
Secondary outcome measures	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
Overall study start date	01/11/2011
Completion date	01/08/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 203; UK Sample Size: 203
Total final enrolment	203
Key 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
Key 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
Date of first enrolment	01/11/2011
Date of final enrolment	01/08/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southmead Hospital

Bristol
BS10 5NB
United Kingdom

Sponsor information

North Bristol NHS Trust (UK)
Hospital/treatment centre

Dept of Anaesthesia
Southmead Hospital
Southmead Road Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom

"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	09/01/2015		Yes	No
Results article	results	01/08/2016		Yes	No
Results article	results	05/02/2018		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
14/02/2018: Publication reference added.
29/06/2016: Publication reference added.
02/07/2014: the overall trial end date was changed from 01/02/2013 to 01/08/2014.