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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.
Full description
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.
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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:
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
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.
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Interventional model
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62 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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