PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Christie Hospital NHS Foundation Trust
Sponsor:
Collaborator:
Christie Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Colin Lunt, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01604005
First received: May 21, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.


Condition Intervention Phase
Mesothelioma
Radiation: Prophylactic Irradiation of Tracts (PIT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention

Resource links provided by NLM:


Further study details as provided by Christie Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Incidence of chest wall tract metastasis 6 months from randomisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomisation to chest wall tract metastasis [ Time Frame: Weeks ] [ Designated as safety issue: No ]
    Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow up for signs of chest wall metastasis

  • Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field) [ Time Frame: Weeks ] [ Designated as safety issue: No ]
    Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow up for signs of chest wall metastasis

  • Acute and late skin radiotherapy toxicity [ Time Frame: Weeks ] [ Designated as safety issue: Yes ]

    Patient will attend hospital at 6, 12, 26 and 52 weeks post randomisation where toxicity to PIT will be assessed.

    CTCAE v4.0 will be used


  • Pain from chest wall tract metastasis [ Time Frame: Weeks ] [ Designated as safety issue: No ]
    Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow for pain scoring using a Visual Analogue Scale (VAS)


Estimated Enrollment: 374
Study Start Date: July 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PIT Arm Radiation: Prophylactic Irradiation of Tracts (PIT)
21 Gy in 3 fractions
Other Name: Radiation
No Intervention: No PIT Arm

Detailed Description:

Mesothelioma is a rare form of cancer affecting the protective lining that covers many of the body's internal organs. The most commonly affected areas are the lungs and internal chest wall. In the UK over 2300 patients are diagnosed with mesothelioma each year and the numbers are increasing.

As part of the diagnosis and treatment of mesothelioma, patients may undergo a procedure which involves inserting a thin tube into the chest wall enabling an internal examination and for any biopsies or samples of fluid to be taken. These procedures can result in the development of skin lumps or nodules along the tract created by inserting the tube. To try and reduce the risk of these nodules developing in the tract or at the site of the scar, radiotherapy can be given to the chest wall at the site of the tract after the procedure has been performed; this type of radiotherapy is known as prophylactic irradiation of tracts or PIT.

Although many hospitals already give patients this type of radiotherapy treatment to the chest wall we still do not know if the treatment works. This trial has been designed to answer the question about the effectiveness of PIT radiotherapy. If PIT is found to be effective in preventing or delaying the development of these skin nodules then it can be offered to all patients as part of their treatment. However, if we discover that PIT is not effective this will save patients from undergoing ineffective treatment and having to spend time making unnecessary extra visits to hospital

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Either sex, age ≥ 18 years
  • Diagnosis of mesothelioma by multi-disciplinary team (MDT). All histological subtypes are eligible for the trial
  • ECOG performance status 0-2 (Appendix C)
  • Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT
  • Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy (mini-thoracotomy), local anaesthetic thoracoscopy or chest drain
  • Able to start radiotherapy within 42 days (6 weeks) of the most recent chest wall procedure
  • Chest wall intervention scar visible at time of randomisation
  • Radiotherapy target volume acceptable by the local radiotherapist
  • Patients enrolled on other clinical trials could be considered after discussion with the chief investigators

Exclusion Criteria:

  • Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)
  • Previous radiotherapy to the region of the chest wall intervention site
  • Indwelling pleural catheter in-situ at the intervention site
  • Patients currently receiving chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604005

Contacts
Contact: Colin Lunt +44 (0) 161 918 7492 colin.lunt@christie.nhs.uk

  Show 61 Study Locations
Sponsors and Collaborators
Colin Lunt
Christie Hospital NHS Foundation Trust
Investigators
Study Chair: Corinne Faivre-Finn The Christie NHS Foundation Trust
Study Chair: Neil Bayman The Christie NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Colin Lunt, Clinical Trials Project Manager, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01604005     History of Changes
Other Study ID Numbers: 08_DOG07_93, ISRCTN04240319, PB-PG-1010-23232
Study First Received: May 21, 2012
Last Updated: June 11, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Christie Hospital NHS Foundation Trust:
Mesothelioma
radiotherapy
prophylactic irradiation of tracts

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014