SBRT for Liver Tumors, Liver Metastases, and Pancreatic Tumors

February 16, 2026 updated by: Institute of Oncology Ljubljana

SBRT of Liver Tumors and Metastases and Pancreatic Tumors

This prospective observational study evaluates the safety and effectiveness of stereotactic body radiotherapy (SBRT) for liver tumors, liver metastases, and pancreatic tumors. The study focuses on systematic monitoring and optimization of the SBRT treatment process, including adherence to the implemented protocol, with the aim of simplifying methods while maintaining treatment safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stereotactic body radiotherapy (SBRT) is an advanced radiotherapy technique that enables delivery of high radiation doses to tumors with high precision while limiting exposure of surrounding healthy tissues. This study prospectively follows patients treated with SBRT for primary liver tumors, liver metastases, and pancreatic tumors at the Institute of Oncology Ljubljana.

The primary aim is to monitor and optimize all steps of the SBRT workflow, including protocol adherence, in order to ensure safe implementation and to evaluate treatment outcomes. The study also aims to assess whether the established SBRT protocol can be simplified without compromising patient safety.

Treatment safety and effectiveness outcomes will be evaluated during follow-up, and the collected data will be used to support further refinement of SBRT procedures for upper gastrointestinal tumors

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with liver tumors, liver metastases, or pancreatic tumors eligible for stereotactic body radiotherapy (SBRT)
  • Planned treatment with SBRT according to institutional protocol
  • Ability to comply with treatment and follow-up procedures
  • Signed informed consent

Exclusion Criteria:

  • Contraindications for SBRT according to institutional radiotherapy protocol
  • Prior radiotherapy that prevents safe SBRT delivery to the target region
  • Severe uncontrolled comorbidities preventing safe SBRT treatment
  • Pregnancy
  • Inability to provide informed consent or comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT Treatment
Patients with liver tumors, liver metastases, or pancreatic tumors treated with stereotactic body radiotherapy (SBRT) according to the institutional protocol.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) delivered according to the institutional protocol for treatment of liver tumors, liver metastases, and pancreatic tumors, with high-dose hypofractionated radiation and image-guided radiotherapy techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Safety (Radiotherapy-Related Toxicity)
Time Frame: From start of SBRT up to 12 months after treatment
Assessment of acute and late treatment-related toxicity after stereotactic body radiotherapy (SBRT) for liver tumors, liver metastases, and pancreatic tumors, evaluated according to standard toxicity criteria.
From start of SBRT up to 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI_SBRT-LIVER-PANCREAS-2019
  • ERID-KSOPKR-0091/2019 (Other Identifier: Ethics Committee, Institute of Oncology Ljubljana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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