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A Study of Pressurized Aerosol Chemotherapy with Cisplatin and Doxorubicin for Patients with Fluid Buildup Around the Lungs Caused by Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with pleural carcinosis, a condition where cancer cells spread to the pleura, which is the thin tissue covering the lungs and lining the inside of the chest wall. When cancer affects this area, fluid can build up between the layers of the pleura, causing what is called a malignant pleural effusion. This fluid buildup can make breathing difficult and cause discomfort. The study will use a treatment method that delivers chemotherapy drugs directly into the chest cavity as a pressurized mist or aerosol. The chemotherapy drugs that will be used are cisplatin and doxorubicin hydrochloride, which are medicines designed to kill cancer cells. This treatment approach is called pressurized intrathoracic aerosol chemotherapy.

The purpose of the study is to see how well this aerosol chemotherapy method works at preventing the fluid from building up again in the chest, a process called pleurodesis. The treatment will be given during a surgical procedure using a technique called video-assisted thoracoscopic surgery, which uses small incisions and a camera to see inside the chest. During this procedure, the chemotherapy drugs will be delivered as an aerosol directly to the affected area in the chest. The study will check how effective this treatment is at controlling the fluid buildup at different time points after the procedure.

Patients in the study will be monitored for several months after receiving the treatment. The study doctors will evaluate whether the fluid in the chest is controlled and will also watch for any side effects or complications that might occur during or after the procedure. The study will also record information about the overall safety of this treatment method and will follow patients to see how they are doing at different time points after the surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial surgical procedure

    You will undergo a surgical procedure called VATS (video-assisted thoracic surgery). This is a type of surgery performed through small incisions in your chest using a camera.

    During this procedure, the surgeon will confirm the diagnosis of pleural carcinosis (cancer cells in the lining of your lungs) if this has not been confirmed before. This will be done through tissue examination during the surgery.

    The main purpose of this surgery is also to perform pleurodesis, which is a treatment to prevent fluid from building up around your lungs.

  2. Step 2

    Pressurized intrathoracic aerosol chemotherapy administration

    During the same surgical procedure, you will receive a treatment called PITAC (pressurized intrathoracic aerosol chemotherapy).

    This treatment involves delivering chemotherapy medications directly into your chest cavity in the form of a pressurized aerosol (fine mist).

    The medications used are cisplatin and doxorubicin hydrochloride. These are anticancer drugs that will be administered as a solution for infusion through intrathoracic use (directly into the chest cavity).

    The specific dosage, frequency, and duration of administration during the procedure will be determined based on the treatment protocol.

  3. Step 3

    First month follow-up assessment

    At 1 month after your surgical procedure, you will have an assessment to evaluate how well the treatment worked.

    The evaluation will measure the volume of fluid around your lungs to determine if the pleurodesis was effective in controlling the malignant pleural effusion (fluid buildup caused by cancer).

    This assessment will follow specific criteria established by the World Health Organization to measure treatment response.

  4. Step 4

    Three-month follow-up assessment

    At 3 months after your surgical procedure, you will have another assessment.

    The same measurements will be taken to check the amount of fluid around your lungs and evaluate the effectiveness of the pleurodesis.

    The response will be categorized as either complete response (no fluid present) or partial response (reduced amount of fluid).

  5. Step 5

    Six-month follow-up assessment

    At 6 months after your surgical procedure, you will have a final assessment.

    This will include the same evaluation of fluid volume around your lungs to determine the long-term effectiveness of the treatment.

    Throughout all follow-up periods, any complications related to the treatment will be monitored and recorded.

  6. Step 6

    Safety monitoring

    During and after the surgical procedure, information about any complications will be recorded.

    Your health status will be monitored at 30 days and 90 days after the surgery.

    This monitoring is part of the safety evaluation of the PITAC treatment.

Who can join the trial?

9 criteria

  • You must have a confirmed diagnosis of pleural carcinosis, which is cancer that has spread to the lining around the lungs, confirmed by testing fluid from around your lungs, or there must be strong signs based on your symptoms and imaging tests that suggest this condition and you need surgery for diagnosis and treatment
  • You must be between 18 and 80 years old
  • Your overall health and ability to carry out daily activities must be good enough for surgery, measured by a scale called ECOG performance status of 2 or less, which means you are able to care for yourself and are up and about more than half of your waking hours
  • You must be healthy enough to receive general anesthesia, which is medication that makes you unconscious during surgery
  • Your doctors must expect that you will live for at least 3 months
  • You must not be eligible for standard cancer treatments that could remove or reduce the cancer
  • You must be willing to sign a written informed consent form, which means you understand and agree to participate in the study
  • If you are a woman who can become pregnant or a man with a female partner who can become pregnant, you must agree to use effective birth control methods starting from your first study visit
  • If you are a woman who can become pregnant, you will need to have a pregnancy test before the treatment procedure

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the available information.
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Investigated drugs

Pressurized intrathoracic aerosol chemotherapy (PITAC) is a treatment method that delivers chemotherapy drugs directly into the chest cavity as a pressurized mist or aerosol. This approach allows the medication to reach the lining of the lungs and chest wall where fluid has built up due to cancer. The treatment aims to help seal the space between the lung and chest wall to prevent fluid from accumulating again.

What is already known about the treatment

PITAC (Pressurized Intrathoracic Aerosol Chemotherapy) – This is an innovative treatment method that delivers chemotherapy drugs directly into the chest cavity as a pressurized aerosol mist during surgery. It is currently being studied in clinical trials as an experimental approach for treating malignant pleural effusion, which is a condition where cancer causes fluid to accumulate around the lungs. The technique works by converting chemotherapy medication into tiny droplets that can penetrate deeper into the pleural tissue where cancer cells are located, while the pressure helps distribute the treatment evenly throughout the chest cavity. This method belongs to the category of localized cancer treatments and aims to prevent fluid buildup by creating adhesion between the lung lining layers while directly targeting cancer cells in the pleural space.

Investigated diseases

Pleural Carcinosis – Pleural carcinosis is a condition where cancer cells spread to the pleura, which is the thin membrane that lines the lungs and chest cavity. This occurs when cancer from another part of the body, such as the lung, breast, or other organs, spreads to the pleural space. As the disease progresses, cancer cells multiply on the pleural surfaces, often causing fluid to accumulate between the layers of the pleura. This fluid buildup, known as malignant pleural effusion, can cause the lung to compress and make breathing difficult. Patients typically experience shortness of breath, chest pain, and cough as the fluid accumulates. The condition represents an advanced stage of cancer spread beyond the original tumor site.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511255-17-00Protocol codePITAC_ MaPEPiEstimated enrolment40 patientsSponsorAzienda Ospedaliero Universitaria Pisana

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).