C22 C78.7
Conditions
Interventions
Group 1: Patients with unresectable primary or secondary liver tumors who will receive single-fraction MR-guided stereotactic ablative radiotherapy
Sponsors
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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 11. 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of local control of the irradiated lesion(s) according to RECIST version 1.1 (Response Evaluation Criteria in Solid Tumors version 1.1) at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of intrahepatic loco-regional control, distant metastasis-free survival and overall survival 2. Evaluation of toxicity 3. Prospective documentation and evaluation of changes in liver function parameters after single-fraction stereotactic ablative radiotherapy during the course of scheduled follow-ups | — |
Countries
Germany
Contacts
Public ContactStefanie Corradini
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU München
Outcome results
None listed