Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
Regina Elena Cancer Institute
37 participants
Dec 15, 2021
INTERVENTIONAL
Conditions
Summary
Investigate the role of consolidative radiotherapy treatment at the thoraco-mediastinal level in the patient suffering from lung microcytoma - extensive disease and treated with chemo-immunotherapy with atezolizumab, in association with maintenance therapy with atezolizumab.
Eligibility
Inclusion Criteria9
- Histological diagnosis of lung microcytoma;
- Age ≥18 years;
- Performance status according to ECOG 0-2;
- Extended disease at the time of first line oncological treatment;
- Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG and brain MRI;
- In at least partial response (defined according to the Recist criteria \[18\]) after treatment chemoimmunotherapy according to the Impower 133 scheme;
- Haematological, respiratory toxicity ≤ G1, other toxicities ≤ G2 at the time of treatment radiotherapy;
- Pulmonary function tests at the time of radiotherapy treatment compatible with irradiation: FEV≥1.2 l or \>40%, DLCO≥50%;
- Written informed consent.
Exclusion Criteria2
- Previous radiotherapy treatment at the thoraco-mediastinal level;
- In disease progression after chemo-immunotherapy treatment.
Interventions
Thoracic radiotherapy using 4D technique by irradiating the initial sites of disease (primary tumor and involved hilo-mediastinal lymph nodes). The treatments must be provided with the modulated intensity technique (IMRT or VMAT), treatments with conformal technique (3DCRT) are not permitted, where necessary, the Simultaneous Integrated Boost (SIB) technique can be used.
Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice
Locations(1)
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NCT06771518