SMILE: Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

Sponsor

Kantonsspital Winterthur KSW (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05406063

Collaborator

Krebsforschung Schweiz, Bern, Switzerland (Other)

162

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Therapy Bone Metastases Pain	Radiation: SBRT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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 Stereotactic multiple fraction radiotherapy
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 Stereotactic multiple fraction radiotherapy

Arm

Intervention/Treatment

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

Stereotactic multiple fraction radiotherapy

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

Stereotactic multiple fraction radiotherapy

Outcome Measures

Primary Outcome Measures

Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Winterthur	Winterthur	Kanton Zürich	Switzerland	8401

Sponsors and Collaborators

Kantonsspital Winterthur KSW
Krebsforschung Schweiz, Bern, Switzerland

Investigators

Principal Investigator: Robert Foerster, MD, Kantonsspital Winterthur KSW

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kantonsspital Winterthur KSW

ClinicalTrials.gov Identifier:

NCT05406063

Other Study ID Numbers:

2022-00631

First Posted:

Jun 6, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Bone Neoplasms

Bone Marrow Diseases

Study Results

No Results Posted as of Aug 18, 2022