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.
Treatment planning of SBRT for multiple metastases usually employs multiple isocenters, one for each target, resulting in multiple treatment plans. Execution of such treatments requires sequential multiple setups and treatment plan verifications. This practice complicates the workflow of SBRT planning and delivery and makes target-by-target treatment lengthy and patient compliance and comfort suboptimal. The investigators hypothesized that single-isocenter SBRT for extracranial multiple metastases is non-inferior in terms of local efficacy as compared to multiple-isocenter SBRT at the same radiation dose prescription.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Stereotactic Body Radiation Therapy
Department of Radiation Oncology, University Hospital Zurich
Zurich, Switzerland
RECRUITINGFreedom from local disease progression at the site of treated metastases
Local control at the site of treated metastases
Time frame: 1 year post-SBRT
Acute adverse events (AEs)
AEs occurring during SBRT and within 3 months post-SBRT
Time frame: 3 months post-SBRT
Late adverse events (AEs)
AEs occurring 3 months post-SBRT and later
Time frame: 12 months post-SBRT
Overall survival
The time from randomization to death from any cause
Time frame: 1 year post-SBRT
Progression-free survival
The time from randomization to cancer progression at any site or death, whichever comes first
Time frame: 1 year post-SBRT
Overall treatment time
Time needed for setup, verification and beam-on
Time frame: During the procedure
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