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

Launched by ODENSE UNIVERSITY HOSPITAL · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial, called OPC5, is exploring a new treatment method known as Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) for patients with a condition called malignant pleural effusion (MPE), which is the buildup of fluid in the space around the lungs due to cancer. The study aims to assess the safety of this treatment, how it affects patients' quality of life, and how well it helps with symptoms like pain and difficulty breathing. Researchers want to see if PITAC can improve the overall experience for patients facing this challenging condition.

To be eligible for the trial, participants must be at least 18 years old, speak and read Danish, and have a confirmed diagnosis of cancer along with visible MPE that requires treatment. They should also have had a drainage procedure done at least 14 days prior to starting the study. Participants will engage in regular assessments, including questionnaires to track their quality of life and symptom relief. It’s important to note that certain health conditions or previous treatments may exclude individuals from participating, as the goal is to ensure the safety of everyone involved.

Gender

ALL

Eligibility criteria

• 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