ClinicalTrials.gg
RecruitingNCT05406063SMILEUpdated May 22, 2025

Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

An interventional study of SBRT in Radiation Therapy, Bone Metastases and Pain, sponsored by Kantonsspital Winterthur KSW. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Kantonsspital Winterthur KSW · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Radiation Therapy
  • Bone Metastases
  • Pain

Browse trials for

03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 162 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Personally signed and dated written ,
  • Histological diagnosis of ,
  • Histologically or radiologically diagnosed bone ,
  • Age ≥ 18 years
  • Pain or under pain control medication

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women,
  • Women of or sexually active males not willing to use effective 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,
  • 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    SBRT with 9 Gy x 3 fractions to the treatment site.

    Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.

    Radiation: SBRT

  • Active comparator
    SBRT with 7 Gy x 5 fractions to the treatment site

    Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.

    Radiation: SBRT

Interventions

  • RadiationSBRT

    Stereotactic multiple fraction radiotherapy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 3 months after treatment

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for May 2025, 35 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 35 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2022
First posted
Jun 6, 2022
StartActual
Jun 1, 2022
Primary completionEst.
May 31, 2025
CompletionEst.
May 31, 2026
Last update
May 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05406063
Lead sponsor
Kantonsspital Winterthur KSW
Collaborators
Krebsforschung Schweiz, Bern, Switzerland
Responsible party
Sponsor
First posted
Jun 6, 2022
Start date
Jun 1, 2022
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2026 (estimated)
Last update
May 22, 2025

Study contacts

Robert Foerster, MD
Contact
robert.foerster@ksw.ch
+4152 266 21 21
Nidar Batifi, RN
Contact
nidar.batifi@ksw.ch
+4152 266 21 21
Robert Foerster, MD
principal investigator · Kantonsspital Winterthur KSW

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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