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

NCT ID: NCT06391242

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-07

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Metastatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Conventional Radiotherapy

Group Type ACTIVE_COMPARATOR

Standard Conventional Radiotherapy

Intervention Type RADIATION

20Gy in 5 fractions

Stereotactic Body Radiotherapy

Group Type EXPERIMENTAL

Stereotactic Body Radiotherapy

Intervention Type RADIATION

30 or 35Gy in 5 fractions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Conventional Radiotherapy

20Gy in 5 fractions

Intervention Type RADIATION

Stereotactic Body Radiotherapy

30 or 35Gy in 5 fractions

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Cancer Trials Group

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, Canada

Site Status RECRUITING

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, Canada

Site Status RECRUITING

Odette Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wendy Parulekar

Role: CONTACT

613-533-6430

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michael Kucharczyk

Role: primary

Timothy Nguyen

Role: primary

519 685-8600

Zahra Kassam

Role: primary

905 895-4521 ext. 6595

Alexander Louie

Role: primary

416 480-4951

Chiaojung Jillian Tsai

Role: primary

416 946-4501

Giuseppina Laura Masucci

Role: primary

514 890-8254

Isabelle Thibault

Role: primary

418 691-5181

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SC29

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.