DRKS00026662
Recruiting
Not Applicable
Prospective evaluation of the safety and efficacy of MR-guided single-fraction stereotactic ablative radiotherapy for inoperable peripheral lung tumors - SINGLE SHOT - SINGLE SHOT LUNG
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM0 sites25 target enrollmentNovember 8, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- C34
- Sponsor
- Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. histologically confirmed inoperable peripheral NSCLC \< 2 cm in diameter and \> 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
- •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.
Outcomes
Primary Outcomes
Not specified
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