Radiation TherapySMILENCT05406063
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
A study testing SBRT in people with Radiation Therapy and Bone Metastases, run by Kantonsspital Winterthur KSW at 2 sites in Switzerland.
Trial summary
To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy, Bone Metastases, Pain
- 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
- 162 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jun 2022to 31 May 2026
- 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
- Personally signed and dated written informed consent,
- Histological diagnosis of malignancy,
- Histologically or radiologically diagnosed bone metastasis,
- Age ≥ 18 years
- Pain or under pain control medication
Who cannot join
- Pregnant or lactating women,
- Women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment,
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.,
- Prior radiotherapy to the intended treatment site,
- Lesions > 5cm in maximum diameter,
- Prior treatment with radioactive isotopes within 30 days of randomisation,
Show all 9Show fewer
- Spinal column, hands, feet, or head as intended treatment site,- Fracture at the intended treatment site,
- Surgery required or previous surgery at the intended treatment site
- Instability of the intended treatment site.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Bern
Bern, 3010
Hossein Hemmatazad, MD
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Robert Foerster, MD, +4152 266 21 21, robert.foerster@ksw.ch
Nidar Batifi, RN, +41052 266 21 21, nidar.batifi@ksw.ch
About this study
Official title: Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy.
- Conditions
- Radiation Therapy, Bone Metastases, Pain
- Being tested
- SBRT
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Stereotactic multiple fraction radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| SBRT with 9 Gy x 3 fractions to the treatment site. | Experimental | Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site. Receives: Radiation: SBRT |
| SBRT with 7 Gy x 5 fractions to the treatment site | Active comparator | Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
The Visual Analog Scale is a validated, subjective measure for pain. Possible scores ranges between zero (no pain) and ten (worst possible pain).
The primary endpoint was defined as pain relief > 2 points from Baseline to 3 months after treatment.
Measured: Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jun 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation TherapyStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland
- Responsible party
- Sponsor
- Investigators
- Robert Foerster, MD, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406063
- Sponsor's protocol ID
- 2022-00631
- Acronym
- SMILE
- Status last verified
- May 2025
- First submitted
- 3 May 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foerster R, Zwahlen DR, Schroeder C, Windisch P, Halatsch ME, Alfieri A, Meier C, Hemmatazad H, Aebersold DM, Buchali A, Habermehl D, Batifi N. SMILE-stereotactic multiple fraction radiotherapy for non-spine bone metastases: study protocol for a multicenter, open-label phase III randomized controlled trial. Trials. 2024 Nov 13;25(1):762. doi: 10.1186/s13063-024-08608-6.
PubMed 39538259
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05406063
- Acronym / sponsor ID
- SMILE / 2022-00631
- Conditions
- Radiation Therapy, Bone Metastases, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 6 Jun 2022 (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.
To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT with 9 Gy x 3 fractions to the treatment site. | Experimental | Radiation: SBRTPatients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site. |
| SBRT with 7 Gy x 5 fractions to the treatment site | Active comparator | Radiation: SBRTPatients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Personally signed and dated written informed consent,
- Histological diagnosis of malignancy,
- Histologically or radiologically diagnosed bone metastasis,
- Age ≥ 18 years
- Pain or under pain control medication
Key exclusion criteria (9 listed)
- Pregnant or lactating women,
- Women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment,
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.,
- Prior radiotherapy to the intended treatment site,
- Lesions > 5cm in maximum diameter,
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 multiple fraction radiotherapy | Radiation | SBRT with 7 Gy x 5 fractions to the treatment site, SBRT with 9 Gy x 3 fractions to the treatment site. |
Primary outcome
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
Time frame: Baseline and 3 months after treatment
The Visual Analog Scale is a validated, subjective measure for pain. Possible scores ranges between zero (no pain) and ten (worst possible pain). The primary endpoint was defined as pain relief > 2 points from Baseline to 3 months after treatment.
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 22 May 2025.
- Derived from this study: PubMed 39538259Foerster R, Zwahlen DR, Schroeder C, Windisch P, Halatsch ME, Alfieri A, Meier C, Hemmatazad H, Aebersold DM, Buchali A, Habermehl D, Batifi N. SMILE-stereotactic multiple fraction radiotherapy for non-spine bone metastases: study protocol for a multicenter, open-label phase III randomized controlled trial. Trials. 2024 Nov 13;25(1):762. doi: 10.1186/s13063-024-08608-6.
- Individual participant dataSharing planned: No
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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.
Robert Foerster, MD principal investigator
Kantonsspital Winterthur KSW
2 sites 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 Radiation Therapy and Bone Metastases, run by Kantonsspital Winterthur KSW at 2 sites 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 5 inclusion and 9 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Robert Foerster, MD (+4152 266 21 21, robert.foerster@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. (time frame: Baseline and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406063, which also lists 1 linked publication.
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 22 May 2025.