Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Francesco Dionisi, Doctor
francesco.dionisi@ifo.gov.it
06-52663098
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 37
Treatments
Experimental: Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab
Patients enrolled during the maintenance phase of chemoimmunotherapy treatment (standard of care) according to the IMPOWER 133 scheme which is divided as follows: 1) initial chemo-immunotherapy phase with IV treatment cycles with carboplatin AUC 5 day 1 and etoposide 100 mg/m2 days 1-3 q21 followed by a maintenance phase with immunotherapy (Atezolizumab day 1 1200 mg i.v. g1 of each cycle) until progression-toxicity.~In association with immunotherapy, all patients will undergo treatment radiotherapy with 45 Gy in 15 fractions of 3 Gy administered 5 days a week on residual disease documented on CT-PET, dose 32.5Gy (2.16Gy for 15 fractions) on lymph node sites in response complete, equivalent to (EQD2 alpha beta 10) at 30 Gy in 3 fractions.
Sponsors
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov

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