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Pressurized intrathoracic aerosol chemotherapy (PITAC) in patients with malignant pleural effusion: a single-center phase II trial. PITAC_ MaPEPi

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511255-17-00
Acronym
PITAC_ MaPEPi
Enrollment
40
Registered
2025-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural carcinosis

Brief summary

PITAC efficacy will be evaluated in terms of pleurodesis and therefore of the control of the entity of MPE volume at 1, 3 and 6 months after the surgical procedure. Therapeutic efficacy will be assessed according to the criteria of the WHO for the treatment response of MPE after surgery. In this study, the effective objective response in terms of pleurodesis after PITAC will include CR and PR.

Detailed description

The safety of PITAC measured in terms of complications and mortality. For this purpose, intra- and post-operative variables will be recorded, in addition to the demographic and clinical characteristics of the study population. Mortality at 30- and 90-days from the surgical procedure will be recorded

Interventions

DRUGDOXORUBICINA ACCORD HEALTHCARE ITALIA 2 mg/ml concentrato per soluzione per infusione

Sponsors

Azienda Ospedaliero Universitaria Pisana
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PITAC efficacy will be evaluated in terms of pleurodesis and therefore of the control of the entity of MPE volume at 1, 3 and 6 months after the surgical procedure. Therapeutic efficacy will be assessed according to the criteria of the WHO for the treatment response of MPE after surgery. In this study, the effective objective response in terms of pleurodesis after PITAC will include CR and PR.

Secondary

MeasureTime frame
The safety of PITAC measured in terms of complications and mortality. For this purpose, intra- and post-operative variables will be recorded, in addition to the demographic and clinical characteristics of the study population. Mortality at 30- and 90-days from the surgical procedure will be recorded

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026