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Trial Title:
Effect of HITHOC After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma
NCT ID:
NCT05508555
Condition:
Malignant Pleural Mesothelioma
Chemotherapy Effect
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
hyperthermic intrathoracic chemotherapy
Description:
application of chemotherapeutic agent intrathoracic under hyperthermic conditions
Arm group label:
HITHOC group
Summary:
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.
Detailed description:
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ain Shams University hospitals
Address:
City:
Cairo
Zip:
02
Country:
Egypt
Status:
Recruiting
Start date:
March 1, 2022
Completion date:
November 2024
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508555