Identifying biomarkers for toxicity in malignant pleural mesothelioma patients treated with radiotherapy
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
Centro di Riferimento Oncologico - Aviano · NCT06637345
This study is trying to find specific markers in the blood that can help predict if patients with malignant pleural mesothelioma will experience serious side effects from high-dose radiotherapy combined with immune treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano (other) |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT06637345 on ClinicalTrials.gov |
What this trial studies
This study focuses on malignant pleural mesothelioma (MPM), a type of cancer affecting the pleural layers surrounding the lungs. It aims to identify circulating biomarkers that can predict severe toxicity in patients undergoing high-dose radiotherapy combined with immune checkpoint inhibitors. By monitoring molecules involved in inflammation and oxidative stress, the study seeks to assess risk factors associated with pulmonary toxicity from these treatments. The goal is to improve patient safety and treatment outcomes by understanding the biological responses to radical radiation therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a histological diagnosis of malignant pleural mesothelioma who have previously undergone chemotherapy and are eligible for radical radiotherapy.
Not a fit: Patients with non-histologically established disease or those with extensive metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of treatment-related toxicity in MPM patients, enhancing their overall treatment experience.
How similar studies have performed: While studies have shown the potential of combining radiotherapy and immunotherapy in other cancers, this specific approach in MPM is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years of age; * Ability to understand, accept and sign consent informed; * Histological diagnosis of malignant pleural mesothelioma; * Previous administration of chemotherapy; * Previous non-radical surgical approach (diagnostic thoracoscopy or R1-R2 surgery); * Subject eligible for or already treated with RT on hemithorax for radical purposes (50 Gy in fractions on hemithorax + possible boost 60 Gy on residual PET+) Exclusion Criteria: * Disease not histologically established * Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease); * Metastatic patient at diagnosis.
Where this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano, Pordenone, Italy (RECRUITING)
Study contacts
- Principal investigator: Alberto Revelant, MD — Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
- Study coordinator: Alberto Revelant, MD
- Email: alberto.revelant@cro.it
- Phone: 0434 659 159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pleural Mesothelioma Malignant