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NCT Number: NCT07407257

SBRT for Liver Tumors, Liver 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic body radiotherapy (SBRT)

Radiation

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

SBRT of Liver Tumors and Metastases and Pancreatic Tumors

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Feb 12, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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