Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

NCT05406063 | Recruiting

• 1 other identifier: 2022-00631
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Radiation Therapy; Bone Metastases; Pain

Outcome Measures

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.

  Baseline and 3 months after treatment

Study Arms (2)

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.

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.

Radiation: SBRT

Interventions

SBRT RADIATION

Stereotactic multiple fraction radiotherapy

SBRT with 7 Gy x 5 fractions to the treatment site; SBRT with 9 Gy x 3 fractions to the treatment site.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator

Study Sites (2)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 39538259 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Foerster, MD

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Foerster, MD

CONTACT

+4152 266 21 21; robert.foerster@ksw.ch

Nidar Batifi, RN

CONTACT

+4152 266 21 21; nidar.batifi@ksw.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: June 6, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)