Comparing Standard Conventional Radiotherapy with Stereotactic Body Radiotherapy for cancer metastatic
Official title: Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Participants With Painful Non-Spine Bone Metastases
- Phase 3
- 2 groups
- Sites in Calgary, Vancouver and 7 more cities
- Recruiting
Interventions
- Radiation therapy
Standard Conventional Radiotherapy
20Gy in 5 fractions
- Radiation therapy
Stereotactic Body Radiotherapy
30 or 35Gy in 5 fractions
Canadian Sites (11)
11 of 11 recruiting
- Recruiting
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
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 siteTrial siteA hospital or clinic where a study is actually run.Read more →
- +Expected overall survival of greater than 6 months as determined by the treating physician
- +Suitable for protocolProtocolThe detailed plan a study must follow.Read more → defined SBRT and CRT.
- +Stable pain with no immediate plan to alter analgesic regimen.
- +Participant consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the trial to document their willingness to participate
- +ECOG performance status of 0-2.
Exclusion
- −Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant/index pain siteTrial siteA hospital or clinic where a study is actually run.Read more →.
- −Bone metastasis arising from a small cell or germ cell.
- −Radionuclide therapy within 30 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −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.
- −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 armArmOne of the groups in a study, each receiving something different.Read more → of the current study).
- −Received systemic chemotherapy within 1 week of the protocolProtocolThe detailed plan a study must follow.Read more → RT, or who are expected/planned to receive chemotherapy within one week of completing protocol RT.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Standard Conventional Radiotherapy.
Registry label: A: Standard Conventional Radiotherapy
Group B receives Stereotactic Body Radiotherapy.
Registry label: B: Stereotactic Body Radiotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 230 people.
The study is currently expected to finish around January 2028.
The main measurement is taken over: 27 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Complete pain response utilizing the Cochran-Mantel-Hanzeal test — measured over 27 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06391242 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Standard Conventional RadiotherapyRadiation
20Gy in 5 fractions
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Stereotactic Body RadiotherapyRadiation
30 or 35Gy in 5 fractions
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 27 months.
The study as a whole is currently expected to finish around 2028-01-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 230 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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)
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.