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

NCT06637345 | Recruiting

• 1 other identifier: CRO-2023-63
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Mesothelioma Malignant

Outcome Measures

Primary Outcomes (1)

• Association between biomarker levels measured at the end of radiation treatment and pulmonary toxicity of grade ≥2 associated with RT developed as an acute (within 6 months) or late (after 6 months) event

  Differences in fold change of selected biomarkers, between subjects experiencing or not experiencing acute or late toxicity

  up to 36 months

Secondary Outcomes (6)

• Relation between the severity of radio-induced toxicity and trend of biomarkers associated with it

  up to 36 months

• Identifying biomarkers associated with lung toxicity potentially predictive of pulmonary fibrosis

  up to 36 months

• Identifying signs of radio-induced immunomodulation among significant changes induced by hemithoracic radical radiotherapy in analysed biomarkers

  up to 36 months

• Association between the levels of biomarkers measured at the end of treatment radiation and overall survival (OS) at 24 months

  24 moths after end of treatment

• To assess the prognostic potential of basal levels of analysed biomarkers

  up to 36 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with non-metastatic MPM previously treated with chemotherapy, undergoing a non-radical long-sparing surgical approach and treated with RT with radical intent (retrospective cohort) or eligible for RT with radical intent (prospective cohort)

You may qualify if:

• 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+)

You may not qualify if:

• Disease not histologically established
• Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease);
• Metastatic patient at diagnosis.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alberto Revelant, MD

  Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Revelant, MD

CONTACT

0434 659 159; alberto.revelant@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 15, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-09

Locations

IT (1)