Condition category
Cancer
Date applied
28/10/2011
Date assigned
28/10/2011
Last edited
29/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Amelia Dunscombe

ORCID ID

Contact details

Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
-
Amelia.Dunscombe@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11023

Study information

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

Acronym

SMART

Study hypothesis

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 patient’s 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

NRES Committee South Central- Southampton B, First MREC approval date 21/09/2011, ref:11/SC/0408

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/11/2011

Overall trial end date

01/08/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 203; UK Sample Size: 203

Participant 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

Recruitment start date

01/11/2011

Recruitment end date

01/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25575875
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27345639

Publication citations

Additional files

Editorial Notes

29/06/2016: Publication reference added. 02/07/2014: the overall trial end date was changed from 01/02/2013 to 01/08/2014.