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临床试验/NCT05508555
NCT05508555招募中不适用

Effect of Intraoperative Hyperthermic Intrathoracic Chemotherapy After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
disease free survival or time to recurrence

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

HITHOC group

Active Comparator

the group that will receive HITHOC after pleurectomy decortication

干预措施: hyperthermic intrathoracic chemotherapy (Procedure)

pleurectomy decortication without HITOC

No Intervention

the group who received pleurectomy decortication without HITHOC

结局指标

主要结局

disease free survival or time to recurrence

时间窗: Through out the whole study with maximum of 2 years

time from clearance of disease till onset of recurrence of same disease

overall survival

时间窗: till mortality of the case or 2 years maximum

survival of the cases till mortality

次要结局

  • comorbidities(Through out the whole study duration with maximum of two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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