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Recruiting NCT06230666

Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases

Trial Parameters

Condition Metastatic Cancer
Sponsor Matthias Guckenberger
Study Type INTERVENTIONAL
Phase N/A
Enrollment 62
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-02-19
Completion 2026-12-30
Interventions
SBRT

Brief Summary

The goal of this randomized non-inferiority clinical trial is to investigate whether single-isocenter SBRT using one treatment plan is similarly effective as multiple-isocenter SBRT using multiple treatment plans for multiple extracranial metastases. The main question it aims to answer is: \- whether 1-year freedom from local disease progression at the site of treated metastases after single-isocenter SBRT is non-inferior against multiple-isocenter SBRT at the same prescription doses. Cancer patients with multiple extracranial distant metastases will be randomly assigned and treated either with single-isocenter SBRT or multiple-isocenter SBRT.

Eligibility Criteria

Inclusion Criteria: * Written informed consent according to Swiss law and ICH/GCP regulations signed and dated by the participant and the investigator before any trial specific procedures (Informed Consent Form); * Distant extracranial metastases (lung, mediastinal/cervical lymph node, liver, bone including spinal/paraspinal and abdominal/pelvic) from histologically confirmed cancer; * Distant metastases confirmed by imaging: * CT is required in all cases; * MRI is required for spinal and recommended for liver metastases; * PET/CT is recommended for tumors showing high uptake of 18F-FDG, 11Ccholine, 68Ga- or 18F-PSMA; * At least 2 distant metastases that are amendable to treat with a single isocenter approach according to the judgment of the treating clinician; * Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures. Exclusion Criteria: * Prior radiotherapy for distant metastases if overlapping previous and current treatment plans lead

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