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Effect of Intrathoracic Aerosol Cisplatin and Doxorubicin on Malignant Pleural Effusion in Patients with Unresectable Pleural Carcinomatosis

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What is this trial about?

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

The study looks at people who have neoplastic pleural effusion, which is fluid that collects around the lungs because of cancer. The treatment being tested uses a special technique called Pressurized IntraThoracic Aerosol Chemotherapy delivered during a short procedure called videothoracoscopy. During this procedure a mist containing two chemotherapy medicines, doxorubicin hydrochloride and cisplatin, is sprayed into the chest space.

The purpose of the study is to see whether this approach can reduce the chance that the fluid returns after treatment. Participants will have the procedure once, stay in the hospital for a short recovery, and then have routine check‑ups that may include a chest X‑ray, an ultrasound of the chest, or a scan of the lungs to see how they are doing.

Follow‑up visits are planned over the next year to monitor any side effects, overall health, breathing comfort, and quality of life. Doctors will ask about symptoms, perform simple tests, and record any problems that arise, such as kidney or liver issues, blood changes, or lung irritation. This information helps determine if the treatment is safe and effective.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
After joining the study, a series of initial examinations are performed to confirm eligibility.
These include a physical examination, chest x‑ray, chest computed tomography (ct) scan, and laboratory tests to evaluate kidney, liver and blood cell function.
The results are used to ensure that the patient can safely receive the upcoming treatment.
Step 2
Surgical preparation and videothoracoscopy
The patient is admitted to the hospital and prepared for surgery under general anesthesia.
A small camera and instruments are introduced into the chest cavity through a videothoracoscopy procedure.
The surgeon inspects the pleural space and places a chest tube to allow drainage after the procedure.
Step 3
Pressurized intrathoracic aerosol chemotherapy (pitac)
During the videothoracoscopy, a pressurized aerosol containing two chemotherapy medicines is administered directly into the chest.
doxorubicin is given at a dose of 10.5 milligrams per square meter of body‑surface area.
cisplatin is given at a dose of 2.1 milligrams per square meter of body‑surface area.
Both medicines are delivered as a solution for infusion and are used only once during this procedure.
The aerosol is kept in the chest cavity for a short, controlled period before the chest tube is re‑connected.
Step 4
Immediate postoperative monitoring
After the aerosol treatment, the patient is observed in the recovery area.
Vital signs, oxygen level and chest‑tube output are checked regularly.
Medical staff look for early signs of complications such as lung injury, bleeding, or infection.
Step 5
Hospital discharge
When the chest tube output is low and the patient is stable, the chest tube is removed.
The patient is then allowed to go home with instructions for activity and signs of problems to watch for.
Step 6
First follow‑up (1 month)
A chest x‑ray is performed to see whether any pleural fluid has returned.
A pleural ultrasound measures the size of any remaining fluid.
The patient completes the eortc qlq‑c30 questionnaire, which evaluates quality of life.
Breathlessness is rated using the mmrc scale.
Laboratory tests are repeated to monitor kidney, liver and blood health, and any adverse events are recorded.
Step 7
Second follow‑up (3 months)
A chest ct scan is done to assess local disease control and look for new pleural nodules.
The eortc qlq‑c30 questionnaire and mmrc dyspnea scale are repeated.
Ultrasound again measures pleural fluid volume.
Post‑operative complications are evaluated according to the clavien classification.
Laboratory tests continue to monitor organ function and safety.
Step 8
Third follow‑up (6 months)
The mmrc dyspnea scale is completed to assess breathing difficulty.
Laboratory tests are performed and any new adverse events are documented.
Step 9
Final follow‑up (12 months)
Overall survival is recorded, noting the time from the pitac procedure to death or last contact.
The eortc qlq‑c30 questionnaire and mmrc dyspnea scale are completed again.
Laboratory tests and imaging are reviewed to detect late adverse events or disease recurrence.
The independent data safety monitoring board reviews the collected safety information.

Who can join the trial?

5 criteria

Be 18 years of age or older, regardless of gender.
Have a diagnosis of malignant pleural effusion (cancer‑related fluid buildup around the lungs) confirmed by tissue testing (looking at cells under a microscope) called histological or cytological analysis, or have a suspected fluid buildup that was confirmed during surgery using a quick test called a frozen section.
Have unresectable pleural carcinomatosis (cancer spread on the lining of the lung that cannot be removed by surgery), no matter if cancer has spread to other parts of the body (metastatic sites) or what type of original cancer (primary malignancy) they have.
Provide free, written informed consent (sign a form showing they understand the study and agree to take part).
Be covered by a social health insurance plan or an equivalent insurance system.

Who cannot join the trial?

11 criteria

Had a previous videothoracoscopy talc pleurodesis (a video‑guided chest surgery that uses talc to stick the lung layers together) for malignant pleural effusion.
Is under a legal protection measure such as guardianship or curatorship.
Is deprived of liberty by a judicial or administrative decision (for example, being in prison).
Has a poor overall health status, shown by a Karnofsky score less than 70 (a scale where higher numbers mean better ability to do daily activities) or a Performance Status greater than 2 (a scale where higher numbers mean more difficulty functioning).
Has a contraindication (a reason not to use) to general anesthesia (the medicine that makes you sleep and not feel pain during surgery).
Is eligible for curative surgical treatment (removal of tumor and heated chemotherapy inside the chest, called cytoreduction + HITHOC) because the cancer is limited.
Has a contraindication to the chemotherapy drugs doxorubicin or cisplatin, such as an allergy/hypersensitivity to the drug or its ingredients, recent use of live attenuated vaccines, use of the cancer drug olaparib, use of the seizure drug phenytoin, severe bone‑marrow suppression (myelosuppression), or organ failure.
Has a contraindication only to cisplatin, such as hearing loss (auditory damage), nerve damage caused by cisplatin (neuropathy), kidney problems defined as a GFR (glomerular filtration rate) less than 40 mL/min (a measure of kidney function calculated by the Cockcroft‑Gault equation), or a low platelet count (≤ 100 G/L) indicating poor bone‑marrow function.
Has a contraindication only to doxorubicin, such as a serious irregular heartbeat (severe arrhythmia), heart failure classified as NYHA class greater than 2 (moderate to severe symptoms) or a Left Ventricular Ejection Fraction (LVEF) less than 50% (a measure of how well the heart pumps blood).
Is pregnant, lactating, or a man or woman who could become pregnant and is not using a highly effective method of contraception during treatment, for 4 months after treatment for men and for 7 months after treatment for women.
Is already participating in another interventional study that could interfere with this trial.

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Centre Hospitalier Lyon Sud
Pierre Benite, France

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Investigated drugs

Doxorubicin
is a chemotherapy drug that works by interfering with the DNA of cancer cells, which helps stop them from growing and dividing. In this study, it is delivered as a liquid that is turned into a fine aerosol and sprayed inside the chest cavity (intrathoracic use) during a minimally invasive video‑assisted procedure. The goal is to target the cancer cells that are causing fluid buildup around the lungs, hoping to reduce the chance that the fluid will return.
Cisplatin
is another chemotherapy medication that damages the DNA of cancer cells, preventing them from multiplying. Like doxorubicin, it is given as a solution that is aerosolized and applied directly into the chest cavity during the video‑assisted thoracic surgery. By delivering the drug straight to the site of the malignant pleural effusion, the trial aims to see if it can help keep the fluid from coming back and improve patient outcomes.

What is already known about the treatment

Doxorubicin
This medication is given as a liquid that is infused directly into the chest cavity (intrathoracic infusion). It is a well‑known chemotherapy drug that has been used for many years and is extensively described in medical literature. It is mainly used to treat a range of cancers, including those that cause malignant pleural effusion. It works by entering cancer cells and interfering with their DNA, which stops the cells from growing and leads them to die; it belongs to the anthracycline class of chemotherapy agents.
Cisplatin
This drug is also supplied as a liquid for infusion into the chest cavity (intrathoracic infusion). Cisplatin is an established chemotherapy agent that has been approved for clinical use and is widely reported in scientific studies. Its primary use is for treating various solid tumors and it is employed in cases of malignant pleural effusion. It kills cancer cells by attaching to their DNA and causing damage that the cells cannot repair; it is classified as a platinum‑based chemotherapy drug.

Investigated diseases

Neoplastic pleural effusion - A buildup of fluid in the space surrounding the lungs caused by cancer cells spreading to the chest lining. The fluid is produced by the tumor and can slowly or rapidly increase in amount. As more fluid collects, it pushes on the lung and makes breathing feel harder. The condition may lead to swelling of the chest wall and reduced lung expansion over time.