NCT06637345
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
Recruiting · Not specified · Centro di Riferimento Oncologico - Aviano · registry updated 2024-10-15
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage. In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes. Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM....
Inclusion
- 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
- Disease not histologically established
- Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease);
- Metastatic patient at diagnosis.