Condition category
Cancer
Date applied
17/05/2012
Date assigned
17/05/2012
Last edited
29/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

More details can be found http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12213

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 below 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 measures

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

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

University/education

Website

http://www.christie.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26817643

Publication citations

Additional files

Editorial Notes

29/01/2016: Publication reference added.