Comparing single-isocenter and multiple-isocenter SBRT for treating multiple metastatic cancers
Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases: a Randomized Controlled Non-inferiority Clinical Trial
This study is testing if a simpler radiation treatment for multiple cancers works just as well as a more complex approach to see if it can make things easier and more comfortable for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06230666 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if single-isocenter stereotactic body radiation therapy (SBRT) is as effective as multiple-isocenter SBRT for patients with multiple extracranial metastases. Participants will be randomly assigned to receive either treatment approach, with the primary outcome being the rate of local disease progression at the treated sites after one year. The study seeks to simplify the treatment process by potentially reducing the number of treatment plans and setups required, thereby improving patient comfort and compliance.
Who should consider this trial
Good fit: Ideal candidates are cancer patients with at least two distant extracranial metastases that can be treated with a single isocenter approach.
Not a fit: Patients who have previously received radiotherapy for their distant metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could streamline the treatment process for patients with multiple metastatic cancers, making it more efficient and comfortable.
How similar studies have performed: While the approach of single-isocenter SBRT is promising, it is still being evaluated for its effectiveness compared to the established multiple-isocenter method, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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 leads to excessive dose to OARs; * Distant metastases with extension into the gastrointestinal tract, skin; * Large inter-lesion distance and location of distant metastases in different organs with different motion patterns; * Women who are pregnant or breast feeding; * Intention to become pregnant during the course of the trial; * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases; * Known or suspected non-compliance, drug or alcohol abuse; * Inability to follow the procedures of the trial, e.g. due to language problems of the participant; * Enrolment of the investigator, his/her family members, employees and other dependent persons. 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.
Where this trial is running
Zurich
- Department of Radiation Oncology, University Hospital Zurich — Zurich, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.