Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases

NCT06230666 | Recruiting

• 1 other identifier: 2023-01904
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Freedom from local disease progression at the site of treated metastases

  Local control at the site of treated metastases

  1 year post-SBRT

Secondary Outcomes (5)

• Acute adverse events (AEs)

  3 months post-SBRT

• Late adverse events (AEs)

  12 months post-SBRT

• Overall survival

  1 year post-SBRT

• Progression-free survival

  1 year post-SBRT

• Overall treatment time

  During the procedure

Study Arms (2)

Single-isocenter SBRT

EXPERIMENTAL

SBRT using a single-isocenter treatment plan

Radiation: SBRT

Multiple-isocenter SBRT

ACTIVE COMPARATOR

SBRT using multiple treatment plans

Radiation: SBRT

Interventions

SBRT RADIATION

Stereotactic Body Radiation Therapy

Multiple-isocenter SBRT; Single-isocenter SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthias Guckenberger: lead

Study Sites (1)

Department of Radiation Oncology, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Dr., Chairman, Radiation Oncology Department

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 30, 2024
• Study Start: February 19, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)