DRKS00026662招募中不适用

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 个研究点目标入组 25 人开始时间: 2021年11月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

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