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Study of Hyperthermic Intrathoracic Chemotherapy with Cisplatin and Pleurectomy versus Standard Care in Patients with Malignant Pleural Effusion

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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 patients with malignant pleural effusion, a condition where cancer causes fluid to build up around the lungs. The trial compares a heated chemotherapy treatment delivered directly into the chest cavity, called hyperthermic intrathoracic chemotherapy (HITHOC), which uses the drug cisplatin and may be combined with a surgical removal of part of the lining of the chest called pleurectomy, against more usual care such as chemical pleurodesis or placement of a indwelling pleural catheter. The purpose of the study is to see which approach can keep the disease from getting worse for a longer time.

Participants are randomly placed into one of the two groups, receive the assigned treatment, and then are followed for several months to watch for changes in the disease and to record how they feel. The main result that researchers will look at is the length of time before the disease progresses, known as progression-free survival. They will also examine other outcomes such as how long patients live overall (overall survival), how their daily wellbeing is affected (quality of life), and whether a scoring system used during surgery (intraoperative pleural disease dissemination score) can predict future outcomes. The study continues until enough information is gathered to compare the two treatment strategies.

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

    Baseline assessment

    After joining the study, you will undergo a series of initial examinations that include medical history review, physical examination, laboratory tests, and imaging studies to document the extent of malignant pleural effusion.

    The results of these assessments are used to confirm eligibility and to provide reference values for later comparisons.

  2. Step 2

    Randomization

    Based on the study design, you will be assigned by chance to one of two groups: the treatment group that receives hyperthermic intrathoracic chemotherapy (hithoc) with or without pleurectomy, or the control group that receives either chemical pleurodesis or an indwelling pleural catheter.

    The assignment is concealed from you and the clinical team until the procedure day.

  3. Step 3

    Surgical treatment (hithoc with or without pleurectomy)

    If you are allocated to the treatment group, you will be taken to the operating room for a thoracic surgery.

    When pleurectomy is indicated, the surgeon will remove the affected pleural lining to reduce tumor burden.

    Following pleurectomy, or directly if pleurectomy is not performed, the chest cavity will be filled with a heated solution containing cisplatin.

    The cisplatin dose is calculated as 150 mg per square meter of body‑surface area and is administered intrapleurally as a solution for infusion.

    The heated solution is circulated within the chest for approximately sixty minutes, after which it is drained and the chest is closed.

  4. Step 4

    Control procedure (chemical pleurodesis or catheter placement)

    If you are allocated to the control group, a standard procedure will be performed to manage the pleural effusion.

    For chemical pleurodesis, a sclerosing agent is introduced into the pleural space to cause the lining to stick together and prevent fluid re‑accumulation.

    Alternatively, an indwelling pleural catheter may be placed, allowing you to drain fluid at home as needed.

  5. Step 5

    Postoperative monitoring

    After the procedure, you will stay in the hospital for observation.

    Vital signs, chest imaging, and laboratory tests will be checked regularly to detect any complications such as infection, bleeding, or respiratory problems.

    Pain management and respiratory therapy will be provided as required.

  6. Step 6

    Follow‑up assessments

    Once discharged, you will attend scheduled follow‑up visits at regular intervals, typically every three months.

    Each visit includes physical examination, imaging studies, and questionnaires to evaluate quality of life.

    The primary outcome measured during follow‑up is progression‑free survival, which tracks the time until the disease worsens.

    Additional assessments include overall survival and any further treatments that may be required.

Who can join the trial?

4 criteria

  • Be older than 18 years.
  • Have a diagnosis of malignant pleural effusion (cancer‑related fluid buildup around the lungs).
  • Be scheduled for a diagnostic thoracoscopy (a procedure that uses a thin camera to look inside the chest and take tissue samples).
  • Have a good overall health status, measured by a LENT score of 1 or 2 (a simple rating that looks at factors such as breathlessness, kidney function, blood count, and type of tumor).

Who cannot join the trial?

3 criteria

  • Active pulmonary or systemic infection: This means you currently have an infection in your lungs or an infection that is affecting your whole body. “Active” indicates the infection is still present and causing symptoms.
  • Any condition that could jeopardize your well‑being or affect study results: If the doctor believes you have another health problem that might put you at risk or make it hard to understand the study’s findings, you would not be eligible.
  • Inability to follow study requirements or the follow‑up schedule: You must be able to do everything the study asks (such as taking medicines or attending visits) and attend the planned check‑ups after treatment.
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Investigated drugs

cisplatin is a chemotherapy medicine that is put directly into the chest cavity. In this trial it is given as a warm (heated) fluid that circulates around the lungs. The heat helps the drug work better, and the medicine aims to kill cancer cells that are causing the fluid buildup in the chest.

Pleurectomy is a surgical procedure where part of the lining around the lungs (the pleura) is removed. This surgery is tested to see if taking away the diseased lining can help control the tumor and improve how long patients stay free of disease.

Chemical pleurodesis is a treatment that uses a special substance introduced into the chest space to make the lung lining stick together. When the lining fuses, it helps stop fluid from building up again, providing relief from breathing problems.

Indwelling pleural catheter placement involves inserting a small, flexible tube into the chest cavity. The tube stays in place so fluid can be drained regularly at home, helping to keep breathing comfortable and reduce the need for repeated hospital visits.

What is already known about the treatment

CISPLATINO SANDOZ - This medication is supplied as a sterile solution for infusion that is given directly into the pleural space (intrapleural use). Cisplatin is an established cancer drug that has been used for many years and is listed in medical guidelines and literature. It is mainly used to treat malignant pleural effusion and other solid tumors by entering cancer cells and forming bonds with DNA, which stops the cells from multiplying and leads to their death. It belongs to the class of platinum‑based antineoplastic agents, often described as alkylating‑like chemotherapy.

Investigated diseases

Malignant pleural effusion - It is a buildup of fluid in the space around the lungs that occurs because cancer cells have spread to the lining of the chest cavity. The fluid contains cancer cells and proteins, causing the amount of fluid to increase over time. As the effusion grows, it can make breathing feel more difficult and may limit lung expansion. The condition usually progresses as the underlying cancer continues to involve the pleural surfaces.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526109-13-00Protocol codeTIC-TAC TrialEstimated enrolment64 patientsSponsorUniversita' Degli Studi Di Torino

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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).