Prospective evaluation of the safety and efficacy of MR-guided single-fraction stereotactic ablative radiotherapy for inoperable peripheral lung tumors - SINGLE SHOT

Recruiting

• Conditions: C34; C78; Malignant neoplasm of bronchus and lung; Secondary malignant neoplasm of respiratory and digestive organs

• Registration Number: DRKS00026662
• Lead Sponsor: Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. local and regional control rate <br>2. cancer-specific, progression-free and overall survival

Secondary Outcome Measures

Name	Time	Method
1. Prospective documentation of changes in pulmonary function parameters after MR-guided single-fraction SABR as part of scheduled follow-up.<br>2. Recording of acute toxicity according to standardized forms.<br>3. Recording of pulmonary events (exacerbation of COPD, pulmonary fibrosis, pulmonary embolism) during follow-up.