An interventional study of SBRT in Metastatic Cancer, sponsored by Matthias Guckenberger. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Matthias Guckenberger · Not applicable, Interventional, and Treatment
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:
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 62 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →This is the only study on the registry with Matthias Guckenberger as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Distant metastases confirmed by imaging:
Exclusion Criteria:
Female participants who underwent hysterectomy and/or bilateral oophorectomy or postmenopausal for longer than 2 years are not considered as being of child bearing potential.
SBRT using a single-isocenter treatment plan
Radiation: SBRT
SBRT using multiple treatment plans
Radiation: SBRT
Stereotactic Body Radiation Therapy
Freedom 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
Plan to share: No — Upon an individual request
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