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

K

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)

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

Trial contacts and locations

2

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Central trial contact

Robert Foerster, MD; Nidar Batifi, RN

Data sourced from clinicaltrials.gov

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