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| Name | Class |
|---|---|
| Krebsforschung Schweiz, Bern, Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Stereotactic multiple fraction radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Foerster, MD | Contact | +4152 266 21 21 | robert.foerster@ksw.ch | |
| Nidar Batifi, RN | Contact | +4152 266 21 21 | nidar.batifi@ksw.ch |
| Name | Affiliation | Role |
|---|---|---|
| Robert Foerster, MD | Kantonsspital Winterthur KSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Recruiting | Winterthur | Canton of Zurich | 8401 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39538259 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| University Hospital Bern | Recruiting | Bern | 3010 | Switzerland |
|