DRKS00027117
Recruiting
Not Applicable
Prospective evaluation of the safety and efficacy of MR-guided single-fraction stereotactic ablative radiotherapy for unresectable primary or secondary liver tumors - SINGLE SHOT LIVER - SINGLE SHOT LIVER
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU München0 sites35 target enrollmentNovember 9, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- C22
- Sponsor
- Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU München
- Enrollment
- 35
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 1\-3 unresectable liver tumors (primary and secondary liver tumors); not immediately adjacent to high\-risk organs of the gastrointestinal tract (stomach, duodenum, jejunum/ileum, colon, etc.). Imaging diagnosis of HCC is sufficient with no need for additional biopsy
- •2\. 1\-3 liver metastases in patients with previously histologically confirmed carcinomas (no hematologic or germ cell tumors); not immediately adjacent to high\-risk organs of the gastrointestinal tract (stomach, duodenum, jejunum/ileum, colon, etc.). Biopsy of metastases for histologically confirmed primarary tumor is not required
- •3\. Maximum diameter of a single metastasis \= 5cm
- •4\. Non\-resectable metastases; patient is not eligible for or refuses surgery
- •5\. Age \= 18 years
- •6\. ECOG Performance Status \= 2
- •7\. Indication for radiotherapy (SBRT) confirmed at the multidisciplinary tumor board
- •8\. Previous surgery, systemic and local ablative therapies (RFA, SBRT, brachytherapy etc.) are allowed
- •9\. Convalescence from previous therapy (such as surgery, systemic therapy or radiotherapy in other regions) with an appropriate interval
- •10\. Adequate liver function
Exclusion Criteria
- •1\. Known contraindications for radiotherapy e.g. severe comorbidities
- •2\. 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).
- •3\. Pregnant and/or breastfeeding
- •4\. Medical or psychological impairments that do not allow proper informed consent or trial participation
- •5\. Lack of legal capacity
Outcomes
Primary Outcomes
Not specified
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