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

NCT05508555 | Unknown

• 1 other identifier: HITHOC after PD in MPM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Pleural Mesothelioma; Chemotherapy Effect

Outcome Measures

Primary Outcomes (2)

• disease free survival or time to recurrence

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

  Through out the whole study with maximum of 2 years

• overall survival

  survival of the cases till mortality

  till mortality of the case or 2 years maximum

Secondary Outcomes (1)

• comorbidities

  Through out the whole study duration with maximum of two years

Study Arms (2)

HITHOC group

ACTIVE COMPARATOR

the group that will receive HITHOC after pleurectomy decortication

Procedure: hyperthermic intrathoracic chemotherapy

pleurectomy decortication without HITOC

NO INTERVENTION

the group who received pleurectomy decortication without HITHOC

Interventions

hyperthermic intrathoracic chemotherapy PROCEDURE

application of chemotherapeutic agent intrathoracic under hyperthermic conditions

HITHOC group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 02, Egypt

RECRUITING

Related Publications (4)

• Cao C, Tian D, Park J, Allan J, Pataky KA, Yan TD. A systematic review and meta-analysis of surgical treatments for malignant pleural mesothelioma. Lung Cancer. 2014 Feb;83(2):240-5. doi: 10.1016/j.lungcan.2013.11.026. Epub 2013 Dec 6.

  PMID: 24360321 BACKGROUND

• Opitz I. Management of malignant pleural mesothelioma-The European experience. J Thorac Dis. 2014 May;6 Suppl 2(Suppl 2):S238-52. doi: 10.3978/j.issn.2072-1439.2014.05.03.

  PMID: 24868442 BACKGROUND

• Friedberg JS, Simone CB 2nd, Culligan MJ, Barsky AR, Doucette A, McNulty S, Hahn SM, Alley E, Sterman DH, Glatstein E, Cengel KA. Extended Pleurectomy-Decortication-Based Treatment for Advanced Stage Epithelial Mesothelioma Yielding a Median Survival of Nearly Three Years. Ann Thorac Surg. 2017 Mar;103(3):912-919. doi: 10.1016/j.athoracsur.2016.08.071. Epub 2016 Nov 5.

  PMID: 27825687 BACKGROUND

• Maziak DE, Gagliardi A, Haynes AE, Mackay JA, Evans WK; Cancer Care Ontario Program in Evidence-based Care Lung Cancer Disease Site Group. Surgical management of malignant pleural mesothelioma: a systematic review and evidence summary. Lung Cancer. 2005 May;48(2):157-69. doi: 10.1016/j.lungcan.2004.11.003. Epub 2005 Jan 5.

  PMID: 15829316 BACKGROUND

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hany Hassan El sayed, prof Dr.

  hanyhassan77@hotmail.com

  STUDY DIRECTOR

Central Study Contacts

Hazem Mohamed Youssef, M.S.C

CONTACT

01115449746; zomayoussef@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 19, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

EG (1)