RECRUITING Phase 3 ClinicalTrials.gov

Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

Sponsor: Canadian Cancer Trials Group • ClinicalTrials.gov ID: NCT06391242

Registry updated: 2026-10-16

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Description

This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)

Interventions

Standard Conventional Radiotherapy (Radiation)
20Gy in 5 fractions
Stereotactic Body Radiotherapy (Radiation)
30 or 35Gy in 5 fractions

Eligibility criteria

Inclusion Criteria: * Histologic confirmation of solid tumour. * Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site * Expected overall survival of greater than 6 months as determined by the treating physician * Suitable for protocol defined SBRT and CRT. * Stable pain with no immediate plan to alter analgesic regimen. * ECOG performance status of 0-2. * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate Exclusion Criteria: * Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant/index pain site. * Bone metastasis arising from a small cell or germ cell. * Radionuclide therapy within 30 days of randomization. * Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study). * Received systemic chemotherapy within 1 week of the protocol RT, or who are expected/planned to receive chemotherapy within one week of completing protocol RT. * Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred intervention if possible. * Pregnant or lactating individuals.

Conditions

Cancer Metastatic

Locations

Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
BCCA - Vancouver — Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
Kingston Health Sciences Centre — Kingston, Ontario, Canada
London Health Sciences Centre Research Inc. — London, Ontario, Canada
Stronach Regional Health Centre at Southlake — Newmarket, Ontario, Canada
Odette Cancer Centre — Toronto, Ontario, Canada
University Health Network — Toronto, Ontario, Canada
Windsor Regional Cancer Centre — Windsor, Ontario, Canada
CIUSSS de l'Est-de-I'lle-de-Montreal — Montreal, Quebec, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada
Hotel-Dieu de Quebec — Québec, Quebec, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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