Doxorubicin hydrochloride for Malignant pleural effusion | Pleural carcinomatosis

Inclusion criteria

• {"criterion_text":"- Confirmed diagnosis (positive preoperative cytological exam of pleural fluid) or high clinical-radiological suspicion of primary or secondary pleural carcinosis requiring surgery (using VATS) for diagnostic and/or staging purposes and pleurodesis intent (in suspected cases, pathologic confirmation will be obtained by intraoperative frozen section)\n- Patients between 18 and 80 years of age\n- Performance status according to ECOG ≤ 2, suitable for general anesthesia\n- Life expectancy of at least 3 months\n- Patients who are not candidates for any exclusive or combined standard cytoreductive treatment\n- Written informed consent\n- Using effective methods of contraception. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as per the CTFG guidance on contraception (version 1.2), starting during study screening visit.\n- Female patients of childbearing age will be included in the study and monitored by pregnancy testing before PITAC procedure."}

Exclusion criteria

• {"criterion_text":"- Impaired cardiac function (history of congestive heart failure or FE <40%)\n- Clinically significant cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrolment), myocardial infarction (<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class > II or serious uncontrolled cardiac Arrhythmia requiring medication)\n- Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min)\n- Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin> 1.5 upper limit of normal)\n- Impaired hematopoietic function (leucocytes <4000/mm3, neutrophils <1500 / mm3, platelets <100000/ mm3)\n- History or presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of PITAC or patient at high risk from treatment complications\n- Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation\n- Participants with newly diagnosed active/latent TB or HBV/HCV/HIV\n- Myelosuppression\n- Ongoing infections\n- Known hypersensitivity to chemotherapeutic agents\n- Contraindications and/or hypersensitivity to surgery and/or general anesthesia\n- Patients with age < 18 and > 80 years, subjects who are incapacitated\n- Pregnant or nursing (breastfeeding) women\n- Patients who do not speak and understand national language"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Efficacy measured as pleurodesis/control of malignant pleural effusion (MPE) volume at 1, 3 and 6 months post-procedure; assessed according to WHO criteria for treatment response of MPE after surgery. Objective responses counted as CR and PR."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Safety assessed by recording intra- and post-operative variables, complications, demographic and clinical characteristics; mortality at 30 and 90 days post-procedure recorded."}

Italy

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

45

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Pisana

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy