Effect of HITHOC After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma

  • End date
    Nov 23, 2024
  • participants needed
  • sponsor
    Ain Shams University
Updated on 4 October 2022


Malignant pleural mesothelioma (MPM) is an aggressive malignancy of the pleural lining with exceptionally poor survival. Median survival from diagnosis is less than 12 months (1). The widespread use of asbestos in past decades together with the long latency of MPM are responsible for the still increasing incidence of MPM (2), affecting 7-40 people per million inhabitants depending on the geographic region (3). The main therapeutic strategies for MPM are surgery, chemotherapy, and radiation therapy (RT). Multimodality treatment for MPM is a topic that has been attracting a lot of attention from researchers, as therapeutic modalities such as surgery, chemotherapy, or radiotherapy have not proven to be effective as single-modality treatments (4). surgery alone is not able to achieve microscopic complete (R0) resection. Therefore, combined treatment modalities have been established in many centres during the last years to achieve a better local tumor control with increasing overall survival (5). In this regard, hyperthermic intrathoracic or intrapleural chemotherapy has been used as one of the multimodality therapies. Intrapleural injection of cytotoxic drugs with hyperthermic perfusion has been proved to enhance cytotoxic effect on tumor cells with limited systemic side effect (6). While cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) has become a standard therapy for intraperitoneal original carcinoma or carcinomatosis peritonei such as pseudomyxoma and colorectal cancer induced ascites (7), limited studies have been reported on the application of hyperthermic intrathoracic chemotherapy (HITHOC) in combination with cytoreductive surgery for the treatment of the malignant pleural mesothelioma (8). With the application of the HITOC after macroscopic complete pleural tumour resection, it is expected to obtain better local tumour control, and thereby improve progression-free as well as overall survival (9).

In this study, we aim to compare results of HITHOC after P/D versus P/D alone in managing patients with localised MPM and our main outcomes are disease free survival, overall survival and possible perioperative complications.


Malignant pleural mesothelioma (MPM) is a fatal malignancy with limited options of therapies including surgery, radiotherapy and chemotherapy (10). extensive tumor extraction can be achieved with either extrapleural pneumonectomy (EPP) or extended pleurectomy/decortication (P/D. However, significant proportion of patients have relapse of the disease following EPP or P/D and they usually die within a few months (11). Thus, surgery-based multimodality therapies have been clinically explored in the past decades. Intraoperative intrapleural injection of cytotoxic drugs, such as cisplatin, doxorubicin, gemcitabine, or epirubicin, with hyperthermic perfusion at the time of surgery, i.e, hyperthermic intrathoracic chemotherapy (HITHOC), is a widely used method of multimodality treatment for MPM to optimize local disease control (12). The most popular cytotoxic drugs used for HITHOC were cisplatin followed by doxorubicin and mitomycin C, and 41-43 ◦C was most commonly used in HITHOC. The standard time for infusion was 60-90 min across the studies. Intrathoracic instillation of chemotherapeutic agents allows for a much higher concentration of the drug in the pleural cavity potentially improving the cytotoxic effect to the tumor cells and minimizing systemic adverse effects (13).

Condition Malignant Pleural Mesothelioma, Chemotherapy Effect
Treatment hyperthermic intrathoracic chemotherapy
Clinical Study IdentifierNCT05508555
SponsorAin Shams University
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

patients presented with localised MPM are the main target and histopathological diagnosis of MPM is made via video-assisted thoracoscopic surgery or open multiple pleural biopsies

Exclusion Criteria

patients with stage III or IV MPM in which cytoreductive surgery has no role
Patients underwent extrapleural pneumonectomy (EPP) as a cytoreductive surgery , because we are focusing on P/D only either conventional P/D or extended P/D
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note