Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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+)

Locations
Other Locations
Italy
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
RECRUITING
Aviano
Contact Information
Primary
Alberto Revelant, MD
alberto.revelant@cro.it
0434 659 159
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 52
Treatments
Retrospective cohort
Patients treated with RT with radical intent from 01 January 2014 to the date of study approval
Prospective cohort
Patients eligible for radical intent radiotherapy treatment radical, from the date of study approval
Related Therapeutic Areas
Sponsors
Leads: Centro di Riferimento Oncologico - Aviano

This content was sourced from clinicaltrials.gov