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.
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;
Previous radiotherapy treatment at the thoraco-mediastinal level;
In disease progression after chemo-immunotherapy treatment.
Single group
Thoracic radiotherapy
RadiationThoracic 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.
Atezolizumab 1200 mg e.v. q21
DrugRadiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice
Evaluate the efficacy of the association between radiotherapy and immunotherapy
The local recurrence rate of the disease at one year will be evaluated, with the aim of considering a % greater than 49.9% as unacceptable, assuming that with the experimental treatment object of this study a % of local recurrences of 30% can be achieved. We will therefore test the hypothesis of a local recurrence rate \>50% vs the hypothesis of a local control \<30%. Assuming a power of 80% and a one-sided significance level of 5%, it will be necessary to enroll 37 patients; if 13 or fewer local recurrences are observed, the study will be considered positive.
Measuring the tolerability
The treatment will be considered feasible and non-toxic if severe toxicity values are found ≥ G3 similar or not higher than previous studies that used thoraco-mediastinal radiotherapy for consolidation after chemotherapy in the setting of small cell lung cancer - Extensive disease. In the present study, considering the use of modern radiotherapy techniques (IMRT or VMAT), the association of immunotherapy with thoracic radiotherapy in the maintenance phase will be considered feasible if an overall toxicity rate ≥ G3 \< 20%, a respiratory toxicity grade ≥ G2 \<10%, a respiratory toxicity grade ≥ G3 \<5% is found. Toxicity will be evaluated according to the CTCAE V5.0 scale.
Click on the lead sponsor to view all of their trials.
