Malignant Pleural MesotheliomaNCT06910449
Hemithoracic Arc Radiotherapy Post Pleural Decortication
A study testing hemithoracic Volumetric Arc Radiotherapy post Pleural decortication in people with Malignant Pleural Mesothelioma, run by Cairo University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- hemithoracic Volumetric Arc Radiotherapy post Pleural decortication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of metastatic disease.
- Underwent Pleural decortication.
- Able to provide informed consent.
Who cannot join
- Poor pulmonary function tests.
- Recurrent or palliative cases.
- Inability to attend full course of Radiotherapy or follow up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
national Cancer Institute Cairo university
Cairo, Fom Elkhalig, 11796
Fom El khalig, 20225328286, Irb@nci.cu.edu.eg
About this study
Official title: 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
Read the 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
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- hemithoracic Volumetric Arc Radiotherapy post Pleural decortication
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemithoracic Volumetric Arc Radiotherapy post Pleural decorticationRadiation
post operative delivery of hemithoracic Volumetric Arc Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| single arm receiving postoperative radiotherapy | Experimental | single arm receiving post operative Radiotherapy to the hemithorax Receives: Radiation: hemithoracic Volumetric Arc Radiotherapy post Pleural decortication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Bi-monthly fashion of minimum 6 months post radiation course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start11 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Gamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910449
- Sponsor's protocol ID
- RO2405-291-047-193
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemithoracic Volumetric Modulated Arc Radiotherapy as Part of Lung-Sparing Multimodality Therapy in Patients With Malignant Pleural Mesothelioma Phase II Trial
- ClinicalTrials.gov ID
- NCT06910449
- Acronym / sponsor ID
- RO2405-291-047-193
- Conditions
- Malignant Pleural Mesothelioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm receiving postoperative radiotherapy | Experimental | Radiation: hemithoracic Volumetric Arc Radiotherapy post Pleural decorticationsingle arm receiving post operative Radiotherapy to the hemithorax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of metastatic disease.
- Underwent Pleural decortication.
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- Poor pulmonary function tests.
- Recurrent or palliative cases.
- Inability to attend full course of Radiotherapy or follow up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemithoracic Volumetric Arc Radiotherapy post Pleural decorticationpost operative delivery of hemithoracic Volumetric Arc Radiotherapy | Radiation | single arm receiving postoperative radiotherapy |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Mesothelioma
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Unresectable Pleural Mesothelioma
Active, not recruitingPhase 1
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Biphasic Mesothelioma, Epithelioid Mesothelioma
Active, not recruitingPhase 1/2
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemithoracic Volumetric Arc Radiotherapy post Pleural decortication in people with Malignant Pleural Mesothelioma, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamal (01000704731, Esraa.gamal@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Radiation Toxicity (time frame: weekly assessment during radiation course and monthly follow up for the first 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.