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

Brief Title

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

Official Title

PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention

Brief Summary

      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.
    

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
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Incidence of chest wall tract metastasis 6 months from randomisation

Secondary Outcome

 Time from randomisation to chest wall tract metastasis

Condition

Mesothelioma

Intervention

Prophylactic Irradiation of Tracts (PIT)

Study Arms / Comparison Groups

 PIT Arm

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Radiation

Estimated Enrollment

375

Start Date

July 2012

Completion Date

April 5, 2017

Primary Completion Date

April 5, 2017

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Corinne Faivre-Finn, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT01604005

Organization ID

08_DOG07_93

Secondary IDs

ISRCTN04240319

Responsible Party

Sponsor-Investigator

Study Sponsor

Brynn Chappell

Collaborators

 The Christie NHS Foundation Trust

Study Sponsor

Corinne Faivre-Finn, Study Chair, The Christie NHS Foundation Trust

Verification Date

January 2018