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

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

NCT ID: NCT06421610

Condition: Malignant Pleural Effusion
Pleural Neoplasms
Quality of Life
Chemotherapy Effect
Chemotherapeutic Toxicity
Pleural Carcinomatosis
Pleural Cavity Effusion

Conditions: Official terms:
Carcinoma
Pleural Effusion, Malignant
Pleural Neoplasms
Pleural Effusion

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Cohort study

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: PITAC
Description: Cisplatin, oxaliplatin and doxorubicin are standard, commercially available intravenous cytostatic drugs in oncologic treatment with alkylating and topoisomerase inhibitor effect, respectively. Based on the available data and experience from 11 PITAC procedures at OPC, PITAC with cisplatin, oxaliplatin and doxorubicin for intrapleural administration is expected to be well tolerated with a minimal of nausea, subcutaneous emphysema and transient chest pains.
Arm group label: PITAC

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).

Detailed description: This is a safety and feasibility study of repeated (minimum two procedures) PITAC directed treatments, and the primary outcome is the number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) and/or surgical complications according to the Clavien-Dindo classification. This study will include consecutive MPE patients until 20 patients have completed at least two PITAC´s. The PITAC directed treatment will be performed in 4 week intervals. Bedside ultrasound, VAS-pain and VAS-breathlessness, and Quality of Life questionnaires will be performed at baseline, one month follow-up and three months follow-up. Patients with MPE who are eligible for surgery are identified during the multidisciplinary tumor (MDT) conference at the Department of Surgery, Odense University Hospital (OUH), and included based on predefined in- and exclusion criteria. Patients with MPE from non-colorectal or -appendix cancer will be treated with a combination of cisplatin and doxorubicin. Patients with MPE from colorectal or appendix cancer will be treated with oxaliplatin. In brief, The PITAC procedure is the application of aerosolized chemotherapy into the pleural cavity using thoracoscopy. PITAC is performed in the prone or lateral position. A double lumen endotracheal tube is used to allow exclusion of the ipsilateral lung, but this is not (always) necessary with the patient in the prone position. The first trocar is placed guided by ultrasound, and after safe positioning a second trocar can be inserted guided by video thoracoscopy. The chemotherapy is applied to the pleural cavity through a nebulizer inserted through one of the trocars and linked to a high-pressure injector. After five minutes the chemotherapy has been delivered to the pleural cavity, and after an additional 30 minutes of simple diffusion, the intrathoracic air saturated with chemotherapy is evacuated through a series of filters. The patients are monitored for a minimum of one day and will after each PITAC directed treatment be screened for adverse events.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Odense PIPAC Center, Department of Surgery, Odense University Hospital

Address:
City: Odense
Zip: 5000
Country: Denmark

Status: Recruiting

Contact:
Last name: Martin Graversen, MD

Phone: +45 30549497
Email: martin.graversen@rsyd.dk

Investigator:
Last name: Martin Graversen, MD, Ph.D.
Email: Principal Investigator

Start date: September 15, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Odense University Hospital
Agency class: Other

Source: Odense University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06421610