C34 C78
Conditions
Interventions
Group 1: Monocentric observational study of patients who underwent MR-guided single-fraction SABR (Stereotactic Ablative Radiotherapy)
Sponsors
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. histologically confirmed inoperable peripheral NSCLC 1 cm from the thoracic wall. 2. histologically confirmed metastatic malignant disease with pulmonary metastases. Biopsy of lung metastasis is not required. Total number of lung metastases of 1-3, not centrally located, with a maximum diameter of = 3 cm each. 3. Age over 18 years 4. ECOG Performance Status 0-2 5. Previous surgery, systemic and local ablative therapies (RFA, SABR, brachytherapy, etc.) are allowed. 6. Indication for radiotherapy confirmed at the multidisciplinary tumor board. 7. Patients are able to understand and willing to sign an IRB-approved informed consent document and adhere to the conditions of the study.
Exclusion criteria
Exclusion criteria: 1. Known contraindications for radiotherapy e.g. severe comorbidities, interstitial lung disease etc. 2. Systemic therapies (cytotoxic or targeted therapies incl. immune checkpoint inhibitors) are paused during radiotherapy (however, allowed in individual cases with high tumor burden after internal discussions at the Department of Radiation Oncology, University Hospital LMU Munich. 3. Significant overlap with a previously treated radiation volume - prior radiotherapy is generally allowed as long as all dose requirements are met in the composite plan (biologically effective doses are calculated for this purpose). 4. Pregnant and/or breastfeeding. 5. Medical or psychological impairments that do not allow proper informed consent or trial participation. 6. Lack of legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. local and regional control rate 2. cancer-specific, progression-free and overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prospective documentation of changes in pulmonary function parameters after MR-guided single-fraction SABR as part of scheduled follow-up. 2. Recording of acute toxicity according to standardized forms. 3. Recording of pulmonary events (exacerbation of COPD, pulmonary fibrosis, pulmonary embolism) during follow-up. | — |
Countries
Germany
Contacts
Public ContactChukwuka Eze
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU
Outcome results
None listed