Thoracic radiotherapy: 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.
Atezolizumab 1200 mg e.v. q21: Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Previous radiotherapy treatment at the thoraco-mediastinal level;
* In disease progression after chemo-immunotherapy treatment.
Primary outcome measure(s)
Evaluate the efficacy of the association between radiotherapy and immunotherapy — 60 months 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.
Trial sites (1)
Facility
City
Region
Status
"Regina Elena" National Cancer Institute
Rome
Rome
Recruiting
More Regina Elena Cancer Institute trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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