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PITALC. Pilot study on the effect of PITAC (Pressurized IntraThoracic Aerosol Chemotherapy) by videothoracoscopy in patients with malignant pleural effusion in the light of the results of a retrospective historical cohort treated with talc pleurodesis by videothoracoscopy
EU CTIS ID: 2025-523482-23-00
What this study is testing
To study the effect of PITAC (Pressurized IntraThoracic Aerosol Chemotherapy) on malignant pleural effusion recurrence in unresectable pleural carcinomatosis patients, regardless of primary malignancy tumor
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥ 18 years old
- Patient with malignant pleural effusion with prior histological or cytological diagnostic OR patient with suspected pleural effusion, proven by frozen section
- Patient with unresectable pleural carcinomatosis whatever the presence of other metastatic site and whatever the diagnosis of the primary malignancy
- Patient who has given free and written informed consent
- Patient affiliated to a social health insurance or assimilated
You likely can't join if
- Patient with a history of videothoracoscopy talc pleurodesis for malignant pleural effusion
- Patient benefiting from a legal protection measure (guardianship or curatorship)
- Persons deprived of their liberty by a judicial or administrative decision
- Patient with altered general condition (Karnofsky score <70 or Performance Status> 2) according to the investigator
- Patient with contraindication to general anesthesia
- Patient eligible for curative surgical treatment (cytoreduction + HITHOC) (limited parietal pleural involvement, limited and peripheral visceral pleural involvement without another metastatic site)
See the full eligibility criteria
- Male or female ≥ 18 years old
- Patient with malignant pleural effusion with prior histological or cytological diagnostic OR patient with suspected pleural effusion, proven by frozen section
- Patient with unresectable pleural carcinomatosis whatever the presence of other metastatic site and whatever the diagnosis of the primary malignancy
- Patient who has given free and written informed consent
- Patient affiliated to a social health insurance or assimilated
- Patient with a history of videothoracoscopy talc pleurodesis for malignant pleural effusion
- Patient benefiting from a legal protection measure (guardianship or curatorship)
- Persons deprived of their liberty by a judicial or administrative decision
- Patient with altered general condition (Karnofsky score <70 or Performance Status> 2) according to the investigator
- Patient with contraindication to general anesthesia
- Patient eligible for curative surgical treatment (cytoreduction + HITHOC) (limited parietal pleural involvement, limited and peripheral visceral pleural involvement without another metastatic site)
- Patient with contraindication to doxorubicin and cisplatin: allergy/hypersensitivity to the product or excipients, association with live attenuated vaccines, association with olaparib, association with phenytoin, myelosuppression or organ failure
- Patient with contraindication to cisplatin only: auditory damage, cisplatin-induced neuropathy, renal impairment defined as GFR < 40 mL/min (Cockcroft-Gault equation) or impaired bone marrow function defined as platelets ≤ 100 G/L
- Patient with contraindication to doxorubicin only: severe arrhythmia, myocardial insufficiency defined as NYHA class >2 or Left Ventricular Ejection Fraction (LVEF) < 50%
- - Female patients who are pregnant, lactating or women or men of child-bearing potential without highly effective methods of contraception during the treatment for men and women, during 4 months after end of treatment for men and during 7 months after end of treatment for women
- Patient participating in another interventional study likely to interfere with this study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.