Hemithoracic Arc Radiotherapy Post Pleural Decortication

April 6, 2025 updated by: Esraa Gamal, Cairo University

Hemithoracic Volumetric Modulated Arc Radiotherapy as Part of Lung-Sparing Multimodality Therapy in Patients With Malignant Pleural Mesothelioma Phase II Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Fom Elkhalig
      • Cairo, Fom Elkhalig, Egypt, 11796
        • Recruiting
        • National Cancer Institute Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm receiving postoperative radiotherapy
single arm receiving post operative Radiotherapy to the hemithorax
Radiation: hemithoracic Volumetric Arc Radiotherapy post Pleural decortication
post operative delivery of hemithoracic Volumetric Arc Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Radiation Toxicity
Time Frame: 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
weekly assessment during radiation course and monthly follow up for the first 6 months
late radiation toxicity
Time Frame: 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
Bi-monthly fashion of minimum 6 months post radiation course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO2405-291-047-193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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