Prophylactic Irradiation of Tracts in mesothelioma

ISRCTN	ISRCTN04240319
DOI	https://doi.org/10.1186/ISRCTN04240319
ClinicalTrials.gov number	NCT01604005
Secondary identifying numbers	12213

Submission date: 17/05/2012
Registration date: 17/05/2012
Last edited: 21/06/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-type-radiotherapy-called-pit-people-tests-lung-cancer-called-mesothelioma-pit

Contact information

Mr Colin Lunt
Scientific

Clinical Trials Co-ordination Unit
The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Phone	+44 (0)161 918 7492
Email	colin.lunt@christie.nhs.uk

Study information

Study design	Randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A phase III randomised trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention
Study acronym	PIT
Study objectives	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(s)	Greater Manchester West Ethics Committee, 04/04/2012, ref: 12/NW/0249
Health condition(s) or problem(s) studied	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
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 study start date	30/05/2012
Completion date	30/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 374; UK Sample Size: 374
Key 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.
Key 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
Date of first enrolment	30/05/2012
Date of final enrolment	30/06/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Christie NHS Foundation Trust

Manchester
M20 4BX
United Kingdom

Sponsor information

Christie Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

550 Wilmslow Road
Manchester
M20 4BX
England
United Kingdom

Website	http://www.christie.nhs.uk/
"ROR"	https://ror.org/03v9efr22

Funders

Funder type

Government

Research for Patient Benefit Programme
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2016
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	27/01/2016		Yes	No

Editorial Notes

21/06/2019: ClinicalTrials.gov stated that this trial was terminated.
11/12/2018: No publications found, verifying study status with principal investigator.
29/01/2016: Publication reference added.