Hemithoracic Arc Radiotherapy Post Pleural Decortication

NCT06910449 | Recruiting DMC

• 1 other identifier: RO2405-291-047-193
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Malignant Pleural Mesothelioma is an aggressive and refractory disease , the most aggressive treatment plan offered to these patients include trimodalitiy approach with chemotherapy as the mainstay of treatment . the rationale of post operative Radiotherapy is to sterilize the post operative volume to reduce local failure meanwhile minimizing toxicities in this trial we are going to assess the safety and efficacy of Radiotherapy in Mesothelioma patients poat Pleural decortication

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (2)

• Acute Radiation Toxicity

  Questionnaire based Follow up about acute Radiation toxicity according to RTOG including dysnea , cough , chest pain , dysnea on effort from grade 1-5

  weekly assessment during radiation course and monthly follow up for the first 6 months

• late radiation toxicity

  follow up of patients using both Questionnaire and performing pulmonary function tests and Echo , focusing on DLCO \& FEV1

  Bi-monthly fashion of minimum 6 months post radiation course

Study Arms (1)

single arm receiving postoperative radiotherapy

EXPERIMENTAL

single arm receiving post operative Radiotherapy to the hemithorax

Radiation: hemithoracic Volumetric Arc Radiotherapy post Pleural decortication

Interventions

hemithoracic Volumetric Arc Radiotherapy post Pleural decortication RADIATION

post operative delivery of hemithoracic Volumetric Arc Radiotherapy

single arm receiving postoperative radiotherapy

Eligibility Criteria

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

You may qualify if:

• Evidence of metastatic disease.
• Underwent Pleural decortication.
• Able to provide informed consent.

You may not qualify if:

• Poor pulmonary function tests.
• Recurrent or palliative cases.
• Inability to attend full course of Radiotherapy or follow up visits.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

national Cancer Institute Cairo university

Cairo, Fom Elkhalig, 11796, Egypt

RECRUITING

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

Central Study Contacts

Gamal

CONTACT

01000704731; Esraa.gamal@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Radiation Oncology

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: April 4, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)