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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Universita’ Di Pisa	Pisa	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.02.2026

Trial locations

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.

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 ID:

2024-511255-17-00

Protocol code:

PITAC_ MaPEPi

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?