Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases (SMILE)

Kantonsspital Winterthur KSW

Status: Enrolling

Conditions: Radiation Therapy; Pain; Bone Metastases

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT05406063

2022-00631

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Radiation: SBRT

SBRT with 7 Gy x 5 fractions to the treatment site

Active Comparator group

Description:

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

Treatment:

Radiation: SBRT