Metastatic CancerNCT06230666
Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases
A study testing SBRT in people with Metastatic Cancer, run by Matthias Guckenberger at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Feb 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, University Hospital Zurich
Zurich, 8091
Indira Madani, MD, PhD, +41 44 255 37 68, indira.madani@usz.ch
About this study
Official title: Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases: a Randomized Controlled Non-inferiority Clinical Trial
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.
Read the detailed 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.
- Conditions
- Metastatic Cancer
- Being tested
- SBRT
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Stereotactic Body Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Single-isocenter SBRT | Experimental | SBRT using a single-isocenter treatment plan Receives: Radiation: SBRT |
| Multiple-isocenter SBRT | Active comparator | SBRT using multiple treatment plans Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from local disease progression at the site of treated metastases
Local control at the site of treated metastases
Measured: 1 year post-SBRT
Secondary outcomes (5)
Acute adverse events (AEs)
AEs occurring during SBRT and within 3 months post-SBRT
Measured: 3 months post-SBRT
Late adverse events (AEs)
AEs occurring 3 months post-SBRT and later
Measured: 12 months post-SBRT
Overall survival
The time from randomization to death from any cause
Measured: 1 year post-SBRT
Progression-free survival
The time from randomization to cancer progression at any site or death, whichever comes first
Measured: 1 year post-SBRT
Overall treatment time
Time needed for setup, verification and beam-on
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start19 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthias Guckenberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthias Guckenberger, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230666
- Sponsor's protocol ID
- 2023-01904
- Other IDs
- 2023
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon an individual request
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases: a Randomized Controlled Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06230666
- Acronym / sponsor ID
- 2023-01904
- Conditions
- Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Matthias GuckenbergerUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-isocenter SBRT | Experimental | Radiation: SBRTSBRT using a single-isocenter treatment plan |
| Multiple-isocenter SBRT | Active comparator | Radiation: SBRTSBRT using multiple treatment plans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTStereotactic Body Radiation Therapy | Radiation | Multiple-isocenter SBRT, Single-isocenter SBRT |
Primary outcome
Freedom from local disease progression at the site of treated metastases
Time frame: 1 year post-SBRT
Local control at the site of treated metastases
5 secondary outcomes
Acute adverse events (AEs)
Time frame: 3 months post-SBRT
Late adverse events (AEs)
Time frame: 12 months post-SBRT
Overall survival
Time frame: 1 year post-SBRT
Progression-free survival
Time frame: 1 year post-SBRT
Overall treatment time
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No. Upon an individual request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Radiation Oncology, University Hospital Zurich
Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Metastatic Cancer, run by Matthias Guckenberger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from local disease progression at the site of treated metastases (time frame: 1 year post-SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.