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Transarterial Chemoperfusion Treatment in Patients with Unresectable Pleural Mesothelioma: A Feasibility Study

ACTRN 12620001264976

Brief Summary

Malignant pleural mesothelioma (MPM) is a rare cancer of the lung lining caused by exposure to asbestos. MPM is regarded as one of the most aggressive solid tumours, with limited treatment options and poor prognosis. Emerging MPM treatment options are of particular interest in Australia where the incidence of MPM is among the highest in the world. One such emerging treatment involves the injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. This approach, termed transarterial chemoperfusion, allows a high concentration of chemotherapy to be delivered directly to the cancer. This study is investigating the safety and effectiveness of transarterial chemoperfusion for the treatment of patients with MPM. We will evaluate tumour response, symptoms, quality of life, progression free survival and overall survival.

Intervention/Treatment

  • Transarterial chemoperfusion.
  • Drug: Cisplatin.
  • Drug: Methotrexate.
  • Drug: Gemcitabine.

Inclusion Criteria

  1. Histologically or cytologically confirmed MPM.
  2. Tumour/s assessed as inoperable or refuses surgery.
  3. The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment.
  4. Failure to respond to first line standard of care chemotherapy.
  5. Have measurable disease, by computed tomography (CT) as per modified Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma.
  6. Ability to understand and the willingness to sign a written informed consent document.
  7. Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study.
  8. An ECOG performance status score <3.
  9. Patient is expected to survive and be available for follow up for at least 12 months.
  10. Patients must have private health insurance to be included in this trial and eligible for treatment at The Wesley Hospital.

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