Actively Recruiting

Age: 18Years +
All Genders
NCT06637345

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

Led by Centro di Riferimento Oncologico - Aviano · Updated on 2024-10-15

52

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • Ability to understand, accept and sign informed consent
  • Histological diagnosis of malignant pleural mesothelioma
  • Previous chemotherapy treatment
  • Previous non-radical surgery such as diagnostic thoracoscopy or R1-R2 surgery
  • Eligible for or already treated with radical hemithorax radiation therapy (50 Gy with possible boost to 60 Gy on residual PET-positive areas)
Not Eligible

You will not qualify if you...

  • Disease not confirmed by histology
  • Progression pattern not suitable for radiation treatment (extensive ipsilateral or metastatic intrathoracic disease)
  • Presence of metastatic disease at diagnosis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, Italy, 33081

Actively Recruiting

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Research Team

A

Alberto Revelant, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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