C34
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - SBRT for centrally located early-stage NSCLC or central lung metastasis - Lesions in which a malignant tumor has been confirmed either by histology/cytology or by clear imaging evidence (suspected CT, growth, FDG scan) - No previous radiotherapy of the thorax and/or mediastinum - BED of at least 70 Gy (a/ß= 10; at least EQD-2 = 62.5 Gy) with highly conformal, image-guided radiotherapy technique - Any fractionation is acceptable as long as the BED is 70 Gy or more (EQD-2 = 62.5 Gy)
Exclusion criteria
Exclusion criteria: - SBRT of peripheral tumors - Pre-irradiation of the thorax and/or mediastinum - Biologically effective dose (BED) of less than 70 Gy (a/ß= 10; minimum EQD-2 = 62.5 Gy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primäry endpoint is acute (= 90 days after end of SBRT) toxicity according to CTCAE version 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| freedom from local progression 3 years after SBRT local and distant recurrence local progression-free survival overall survival and cause of death dose-effect correlation | — |
Countries
Austria, Brazil, Colombia, Cyprus, Germany, Mexico, Peru, Spain, Switzerland
Contacts
Klinik für Strahlentherapie und Radioonkologie der Universitätsklinik Bonn