OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.

Summary

This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).

Eligibility

Inclusion Criteria:

* Symptomatic MPE visible with bedside ultrasound
* Histologically or cytologically verified malignancy
* Status CT-scan not older than four weeks
* MPE requiring at least one drainage procedure
* Drained ≥ 14 days before the first PITAC directed treatment
* Bidirectional systemic chemotherapy or immunotherapy ≥ 14 days before the first PITAC directed treatment or no simultaneous systemic chemotherapy or immunotherapy
* ECOG Performance status 0-2
* Life expectancy ≥ 3 months
* Age ≥ 18 years
* Danish-speaking and reading patients
* Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

* A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin
* Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation)
* Myocardial insufficiency, defined as NYHA class \> 2
* Impaired liver function defined as bilirubin ≥1.5
* Fertility, pregnancy and lactation: Female subjects will be considered of non-reproductive potential if they are either a, b or c:

  1. postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
  2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
  3. have a congenital or acquired condition that prevents childbearing. Previous intrathoracic chemotherapy, intrathoracic antibody treatment or chemical pleurodesis
* Any other condition or therapy, which in the investigator´s opinion may pose a risk to the patient or interfere with the study objects

Conditions8

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