Small Cell Lung Cancer
Conditions
Brief 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.
Detailed description
Prospective phase II study on patients affected by extensive-stage small cell lung cancer. The traditional treatment of lung microcytoma-extensive disease consists in platinum and etoposide-based chemotherapy. Radiotherapy of consolidation at the thoracic mediastinal level after chemotherapy may have an impact on survival and can be offered to patients in response to chemotherapy. Studies have recently shown that the addition of immunotherapy with atezolizumab to traditional chemotherapy improves survival compared to placebo. However, the use of consolidation radiotherapy was not permitted in the study thoracic level. Therefore the objective is to evaluate the efficacy and tolerance of the thoracic radiotherapy-immunotherapy association in the maintenance phase with atezolizumab of the treatment of lung microcytoma - extensive disease treated with chemo-immunotherapy.
Interventions
RADIATIONThoracic 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.
DRUGAtezolizumab 1200 mg e.v. q21
Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice
Sponsors
Regina Elena Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
pharmacological interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring the tolerability | 60 months | 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. |
Countries
Italy
Contacts
CONTACTFrancesco Dionisi, Doctor
Outcome results
None listed