Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Colin Lunt
ORCID ID
Contact details
Clinical Trials Co-ordination Unit
The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom
+44 (0)161 918 7492
colin.lunt@christie.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01604005
Protocol/serial number
12213
Study information
Scientific title
A phase III randomised trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention
Acronym
PIT
Study hypothesis
The PIT (Prophylactic Irradiation of Tracts) trial will determine the efficacy, as assessed by the incidence of chest wall metastasis, of PIT following invasive chest wall intervention in malignant pleural mesothelioma compared to no prophylactic radiotherapy.
Patients will be randomised on a 1:1 basis to receive PIT or No PIT. The trial is a phase III multi-centre trial that aims to recruit 374 patients across the UK.
After randomisation PIT patients will receive 21 Gy over 3 fractions. All patients will be followed up for a total of 52 weeks with regular clinic visits and then followed up over the phone.
The primary endpoint is Incidence of chest wall tract metastasis 6 months from randomisation. The secondary endpoints are: time from randomisation to chest wall metastasis; position of metastasis in relation to radiation field for PIT patients; acute and late skin toxicity for PIT patients; and pain from chest wall metastasis evaluated using the Visual Analogue Scale (VAS) pain score
Ethics approval
Greater Manchester West Ethics Committee, 04/04/2012, ref: 12/NW/0249
Study design
Randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Lung Cancer, Mesothelioma
Intervention
Patients who meet the eligibility criteria will be randomised to PIT or No PIT. The PIT patients will receive radiotherapy at 21 Gy in 3 fractions to the intervention (surgery) site. Chemotherapy on both arms is optional. Follow up is for 2 years on both arms (or until chest wall recurrence or death) and includes regular telephone follow up and for the first year patients coming in to the hospital regularly as outpatients.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Efficacy as assessed by the incidence of chest wall metastasis
Secondary outcome measures
1. Toxicity of PIT
2. Time to chest wall metastasis in patients undergoing PIT as compared to no radiotherapy
3. Pain from chest wall metastasis
Overall trial start date
30/05/2012
Overall trial end date
30/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Either sex, age = 18 year
2. Diagnosis of mesothelioma by MDT
3. All histological subtypes. Where the histological diagnosis is unclear, a specialist thoracic pathologist should be consulted.
4. ECOG performance status 0-2.
5. Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT.
6. Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy, local anaesthetic thoracoscopy or chest drain.
7. Able to start radiotherapy within 42 days (6 weeks) from most recent chest wall intervention.
8. Chest wall intervention scar visible at time of randomisation.
9. No indwelling pleural catheters in-situ at the intervention site
10. RT target volume acceptable by the local radiotherapist.
11. No previous open thoracotomy.
12. No previous radiotherapy to the region of the chest wall intervention site.
13. Not currently receiving chemotherapy and not received chemotherapy for mesothelioma before randomisation
14. No other previous or concomitant illness or treatment which in the opinion of the clinician will interfere with the trial treatments or comparisons.
15. Patients enrolled on other clinical trials could be considered after discussion with the chief investigators.
16. Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception.
17. Patients must not be breastfeeding
18. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
19. Before patient registration/randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.
20. Patients can only be randomised in this trial once.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 374; UK Sample Size: 374
Participant exclusion criteria
1. Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)
2. Previous radiotherapy to the region of the chest wall intervention site
3. Patients currently receiving chemotherapy
Recruitment start date
30/05/2012
Recruitment end date
30/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Christie Hospital NHS Foundation Trust (UK)
Sponsor details
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/12/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26817643