Looks for blood markers of lung side effects from high-dose radiotherapy in pleural mesothelioma
Studies blood markers that may predict lung side effects in adults with pleural mesothelioma.
Plain-language title generated from the registry record
Registry title: Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
Key facts
- Where
- Aviano, ItalySee the site
Where in Italy
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCSAviano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centro di Riferimento Oncologico - Aviano
- Trial code
- NCT06637345
- Record updated
- 15 October 2024
- Original description
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.Read full original descriptionShow less
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
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.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
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.