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

Recruiting

• Conditions: C78.7; C22; Malignant neoplasm of liver and intrahepatic bile ducts; Secondary malignant neoplasm of liver and intrahepatic bile duct

• Registration Number: DRKS00027117
• Lead Sponsor: Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Evaluation of intrahepatic loco-regional control, distant metastasis-free survival and overall survival<br>2. Evaluation of toxicity<br>3. Prospective documentation and evaluation of changes in liver function parameters after single-fraction stereotactic ablative radiotherapy during the course of scheduled follow-ups