Comparing single-isocenter and multiple-isocenter SBRT for treating multiple metastatic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Radiation Oncology, University Hospital Zurich
  Zurich, Switzerland Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.