Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
NCT ID: NCT06391242
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
230 participants
INTERVENTIONAL
2025-03-07
2028-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Conventional Radiotherapy
Standard Conventional Radiotherapy
20Gy in 5 fractions
Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy
30 or 35Gy in 5 fractions
Interventions
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Standard Conventional Radiotherapy
20Gy in 5 fractions
Stereotactic Body Radiotherapy
30 or 35Gy in 5 fractions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Arjun Sahgal
Role: STUDY_CHAIR
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Tim Nguyen
Role: STUDY_CHAIR
London Regional Cancer Program, London, ON, Canada
Locations
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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
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hotel-Dieu de Quebec
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Michael Kucharczyk
Role: primary
Timothy Nguyen
Role: primary
Zahra Kassam
Role: primary
Alexander Louie
Role: primary
Chiaojung Jillian Tsai
Role: primary
Giuseppina Laura Masucci
Role: primary
Isabelle Thibault
Role: primary
Other Identifiers
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SC29
Identifier Type: -
Identifier Source: org_study_id
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