Which radiotherapy plan best eases bone metastasis symptoms?
NCT ID NCT03694015
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study compared two ways of giving palliative radiotherapy to people with cancer that has spread to the bones. The goal was to see which method better controls nausea and vomiting caused by radiation, while also managing pain. About 160 adults with bone metastases took part, receiving either a simple standard plan or a more advanced 3D conformal plan. The study was stopped early, but the results help doctors understand how to improve quality of life during treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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160 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 or older * Able to provide informed consent * Clinical diagnosis of cancer with bone metastases (biopsy not required) * Currently being managed with palliative intent RT to 1-3 RT fields for bone metastases, at least one RT field (PTV) must (at least) partly lie within T11-L5 or pelvis. * ECOG Performance Status 0-3 * Patient has been determined to potentially benefit from 8 Gy or 20 Gy * Radiation Oncologist is comfortable prescribing 8 Gy in 1 fraction or 20 Gy in 5 fractions RT for bone metastases * Negative pregnancy test result for women of child-bearing potential * The baseline assessment must be completed within required timelines, prior to randomization. * Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * For simplicity of planning, expected GTV should be less than 20 cm based on radiological or clinical evidence * Patient must be prescribed a 5-HT3 receptor antagonist (e.g. Ondansetron) as antiemetic prophylaxis prior to RT start. * Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study, via paper or using PatientPortals.ca or REDCap if they provide their email address on the informed consent Exclusion Criteria: * Serious medical co-morbidities precluding radiotherapy * Clinical evidence of spinal cord compression * Spinal cord in treatment field has already received at least \>30 Gy EQD2 * Whole brain radiotherapy (WBRT) within 4 weeks of RT start or planned WBRT in the first 4 weeks after last RT * Solitary plasmacytoma * Pregnant or lactating women * Target volume cannot be encompassed by a single VMAT isocentre * Custom mould room requirements (shells and other immobilization that is standard-of-care is acceptable) * Greater than two organs-at-risk requiring optimization. * Patients requiring treatments outside standard clinical hours * Implanted electronic device within 10 cm of the RT fields * Prostheses in the axial plane of the target, or within 1 cm of the PTV out-of-plane * Previous RT that requires an analysis of cumulative dose (i.e. sum plans or EQD2 calculations) * Oral or IV contrast if the local standard-of-care requires compensation for this in planning.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BC Cancer
Prince George, British Columbia, V2M 7E9, Canada
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BC Cancer
Vancouver, British Columbia, Canada
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BC Cancer - Victoria
Victoria, British Columbia, Canada
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London Health Sciences Centre
London, Ontario, Canada
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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