Cancer MetastaticPhase 3NCT06391242
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
A Phase 3 study testing Standard Conventional Radiotherapy and Stereotactic Body Radiotherapy in people with Cancer Metastatic, run by Canadian Cancer Trials Group at 12 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Metastatic
- What is being tested?
- Standard Conventional Radiotherapy and Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 12 sitesCanada
- Study dates
- 7 Mar 2025to 1 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Canada12 sites, 12 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Marc Kerba, 403 521-3164
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Anand Swaminath, 905 387-9495 ext. 64706
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Michael Kucharczyk
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9
Timothy Nguyen, 519 685-8600
- Recruiting
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec, H1T 2M4
Peter Vavassis, 514 252-3425
- Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Giuseppina Laura Masucci, 514 890-8254
- Recruiting
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9
Zahra Kassam, 905 895-4521 ext. 6595
- Recruiting
Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Isabelle Thibault, 418 691-5181
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Alexander Louie, 416 480-4951
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Chiaojung Jillian Tsai, 416 946-4501
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Emma Dunne, 604 877-6000 ext. 672773
- Recruiting
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Stephen Tran, 519 253-5253
About this study
Official title: 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
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)
Read the detailed description
This is a multi-centre, phase III randomized controlled trial comparing SBRT to conventional palliative EBRT in patients with solid tumours and a dominant painful non-spine bone metastasis as defined by a worst pain score of 2 or greater. 230 participants will be enrolled to the study. Participants will have radiation for 5 treatments (conventional palliative EBRT 20Gy/5; SBRT 30Gy/5 or 35Gy/5) and then will be followed for pain response and radiological progression at 3 and 6 months post treatment.
- Conditions
- Cancer Metastatic
- Being tested
- Standard Conventional Radiotherapy, Stereotactic Body Radiotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Conventional RadiotherapyRadiation
20Gy in 5 fractions
Stereotactic Body RadiotherapyRadiation
30 or 35Gy in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Standard Conventional Radiotherapy | Active comparator | Not described Receives: Radiation: Standard Conventional Radiotherapy |
| Stereotactic Body Radiotherapy | Experimental | Not described Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pain response utilizing the Cochran-Mantel-Hanzeal test
Measured: 27 months
Secondary outcomes (8)
Pain response pattern at 3 months: partial, stable or progressive pain
Measured: 27 months
Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);
Measured: 27 months
Re-irradiation rate within the 6-month follow-up period
Measured: 27 months
Incidence of fracture at the radiation target site
Measured: 27 months
Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5
Measured: 27 months
Imaging-based local control rates at 3 and 6 months post-treatment
Measured: 27 months
Patient reported outcomes utilizing EORTC QLQ-C30
Measured: 27 months
Patient reported outcomes utilizing EORTC QLQ-BM22
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 Mar 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Trans Tasman Radiation Oncology Group
- Responsible party
- Sponsor
- Investigators
- Arjun Sahgal, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, CanadaTim Nguyen, Study chair, London Regional Cancer Program, London, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391242
- Sponsor's protocol ID
- SC29
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06391242
- Acronym / sponsor ID
- SC29
- Conditions
- Cancer Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Trans Tasman Radiation Oncology Group
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This is a multi-centre, phase III randomized controlled trial comparing SBRT to conventional palliative EBRT in patients with solid tumours and a dominant painful non-spine bone metastasis as defined by a worst pain score of 2 or greater. 230 participants will be enrolled to the study. Participants will have radiation for 5 treatments (conventional palliative EBRT 20Gy/5; SBRT 30Gy/5 or 35Gy/5) and then will be followed for pain response and radiological progression at 3 and 6 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Conventional Radiotherapy | Active comparator | Radiation: Standard Conventional Radiotherapy |
| Stereotactic Body Radiotherapy | Experimental | Radiation: Stereotactic Body Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Conventional Radiotherapy20Gy in 5 fractions | Radiation | Standard Conventional Radiotherapy |
| Stereotactic Body Radiotherapy30 or 35Gy in 5 fractions | Radiation | Stereotactic Body Radiotherapy |
Primary outcome
Complete pain response utilizing the Cochran-Mantel-Hanzeal test
Time frame: 27 months
8 secondary outcomes
Pain response pattern at 3 months: partial, stable or progressive pain
Time frame: 27 months
Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);
Time frame: 27 months
Re-irradiation rate within the 6-month follow-up period
Time frame: 27 months
Incidence of fracture at the radiation target site
Time frame: 27 months
Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5
Time frame: 27 months
Imaging-based local control rates at 3 and 6 months post-treatment
Time frame: 27 months
Patient reported outcomes utilizing EORTC QLQ-C30
Time frame: 27 months
Patient reported outcomes utilizing EORTC QLQ-BM22
Time frame: 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjun Sahgal study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Tim Nguyen study chair
London Regional Cancer Program, London, ON, Canada
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Conventional Radiotherapy and Stereotactic Body Radiotherapy in people with Cancer Metastatic, run by Canadian Cancer Trials Group at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Parulekar (613-533-6430, wparulekar@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pain response utilizing the Cochran-Mantel-Hanzeal test (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.