Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKantonsspital Winterthur KSW
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Personally signed and dated written informed consent,
Histological diagnosis of malignancy,
Histologically or radiologically diagnosed bone metastasis,
Age ≥ 18 years
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
SBRT
RadiationStereotactic multiple fraction radiotherapy
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: SBRT with 9 Gy x 3 fractions to the treatment site.Experimental treatment 1 intervention
Group B: SBRT with 7 Gy x 5 fractions to the treatment siteActive comparator 1 intervention
Trial outcomes
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 treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kantonsspital Winterthur KSW
Lead sponsor
Krebsforschung Schweiz, Bern, Switzerland
Collaborator
Source ClinicalTrials.gov