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Clinical Trials in Canada / NCT06391242
Recruiting Phase 3

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

NCT06391242 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-03-07
Last updated
2026-08-11

Condition(s) studied

Cancer Metastatic

Investigational drug(s) / intervention(s)

Standard Conventional RadiotherapyStereotactic Body Radiotherapy

Standard Conventional Radiotherapy: 20Gy in 5 fractions

Stereotactic Body Radiotherapy: 30 or 35Gy in 5 fractions

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

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

More Canadian Cancer Trials Group trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06391242 on ClinicalTrials.gov ↗ ← All trials in Canada