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Clinical Trials/DRKS00026662
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.

Registry
who.int
Start Date
November 8, 2021
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM

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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