Evaluation of stereotactic body radiation therapy (SBRT) of centrally located lung tumors (Lungtech-RETRO)
PIs:
Prof. Dr. Eleni Gkika (Freiburg/Bonn)
Prof. Dr. Ursula Nestle (Mönchengladbach)
Contact: eleni.gkika@uniklinik-freiburg.de
Status:
Recruiting centers
Study design:
● Multi-center, international, retrospective data collection
Patient Cohort:
● Primary non-metastatic NSCLC in patients scheduled for SBRT of centrally located tumors
● Solitary or oligometastatic pulmonary metastasis scheduled for SBRT of centrally located tumors
Primary Objective:
● to assess the safety of SBRT in patients with centrally located lung tumors (early stage NSCLC and pulmonary metastases).
Secondary Objective:
● to assess the effectiveness of SBRT in patients with centrally located lung tumors (early stage NSCLC and pulmonary metastases)
● to assess the patterns of local and distant recurrence
● to assess overall survival and cause of death.
● to assess dose-effect correlations for mediastinal organs at risk
Key Inclusion Criteria:
● SBRT in centrally located (defined as tumor within 2 cm or touching the zone of the proximal bronchial tree or tumor that is immediately adjacent to the mediastinal or pericardial pleura, with a PTV expected to touch or include the pleura mediastinal) early stage NSCLC or pulmonary metastasis.
● Lesions confirmed by either histology or cytology or clear imaging signs (CT-suspicion, growth, FDG uptake) of malignant tumors
● No previous radiation in the thorax and / or mediastinum
● Patients must have received a Biologically Effective Dose (BED) of at least 70 Gy (α/β= 10; minimum EQD-2 ≥ 62.5 Gy) with highly conformal, image-guided radiotherapy techniques. Any fractionation is acceptable, as long as the BED is 70 Gy or more (EQD-2 ≥ 62.5 Gy)
Exclusion Criteria:
● SBRT of peripheral tumors
● previous radiation in the thorax and / or mediastinum
● Biologically Effective Dose (BED) of less than 70 Gy (α/β= 10; minimum EQD-2 ≥ 62.5 Gy)