Clinical trial · Interventional
OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
Implementation and Evaluation of Pressurized Intrathoracic Aerosol Chemotherapy (PITAC) for the Treatment of Patients With Malignant Pleural Effusion. A Danish Phase I Study (OPC5 Study)
NCT06421610CI-TRIAL-00077298unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Malignant Pleural Effusion | — | UNRESOLVED | — |
| Pleural Carcinomatosis | Pleural Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Pleural Cavity Effusion | — | UNRESOLVED | — |
| Pleural Neoplasms | Pleural Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PITAC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PITAC
- description
- Malignant Pleural Effusion (MPE) from colorectal or appendix cancer will be treated with Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. MPE from non-colorectal or -appendix cancer will be treated with PITAC using cisplatin 10.5 mg/m2 in 150 ml saline and 2.1 mg/m2 in 50 ml saline. PITAC is performed with a intrapleural pressure of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 300 PSI and a flow-rate of 0.5-1.8 ml/min. The PITAC directed treatment will be planned with 4 week intervals and patients may receive bi-directional systemic chemotherapy simultaneously.
- interventionNames
- Drug: PITAC
Primary outcomes (2)
- measure
- Medical adverse events
- timeFrame
- 30 days from PITAC directed treatment
- description
- Number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 defined as CTCAE ≥ 4 within 30 days after the procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.