NCT07407257

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

February 6, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

SBRTstereotactic body radiotherapyliver tumorpancreatic tumor

Outcome Measures

Primary Outcomes (1)

  • Treatment Safety (Radiotherapy-Related Toxicity)

    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

Study Arms (1)

SBRT Treatment

EXPERIMENTAL

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)

Interventions

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.

SBRT Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Liver NeoplasmsPancreatic NeoplasmsCarcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations