Hemithoracic Arc Radiotherapy Post Pleural Decortication

Not Applicable

Recruiting

• Conditions: Malignant Pleural Mesothelioma

• Registration Number: NCT06910449
• Lead Sponsor: Cairo University

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

Detailed Description

This study will include malignant Pleural Mesothelioma patients treated by trimodalitiy approach starting with neoadjuvant chemotherapy followed by surgery in the form of Pleural decortication then all patients will receive post operative hemithoracic radiation

Study Timeline

• Study Start: 2024-11-11
• Study First Submitted: 2024-12-19
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-11
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute Radiation Toxicity	weekly assessment during radiation course and monthly follow up for the first 6 months	Questionnaire based Follow up about acute Radiation toxicity according to RTOG including dysnea , cough , chest pain , dysnea on effort from grade 1-5
late radiation toxicity	Bi-monthly fashion of minimum 6 months post radiation course	follow up of patients using both Questionnaire and performing pulmonary function tests and Echo , focusing on DLCO \& FEV1

Trial Locations

Locations (1)

national Cancer Institute Cairo university; 🇪🇬 Cairo, Fom Elkhalig, Egypt