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

August 10, 2026 updated by: Canadian Cancer Trials Group

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
        • Contact:
          • Marc Kerba
          • Phone Number: 403 521-3164
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BCCA - Vancouver
        • Contact:
          • Emma Dunne
          • Phone Number: 672773 604 877-6000
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre at Hamilton Health Sciences
        • Contact:
          • Anand Swaminath
          • Phone Number: 64706 905 387-9495
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre
        • Contact:
          • Michael Kucharczyk
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre Research Inc.
        • Contact:
          • Timothy Nguyen
          • Phone Number: 519 685-8600
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Recruiting
        • Stronach Regional Health Centre at Southlake
        • Contact:
          • Zahra Kassam
          • Phone Number: 6595 905 895-4521
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network
        • Contact:
          • Chiaojung Jillian Tsai
          • Phone Number: 416 946-4501
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre
        • Contact:
          • Alexander Louie
          • Phone Number: 416 480-4951
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM-Centre Hospitalier de l'Universite de Montreal
        • Contact:
          • Giuseppina Laura Masucci
          • Phone Number: 514 890-8254
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l'Est-de-I'lle-de-Montreal
        • Contact:
          • Peter Vavassis
          • Phone Number: 514 252-3425
      • Québec, Quebec, Canada, G1R 2J6
        • Recruiting
        • Hotel-Dieu de Quebec
        • Contact:
          • Isabelle Thibault
          • Phone Number: 418 691-5181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Conventional Radiotherapy
Radiation: Standard Conventional Radiotherapy
20Gy in 5 fractions
Experimental: Stereotactic Body Radiotherapy
Radiation: Stereotactic Body Radiotherapy
30 or 35Gy in 5 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete pain response utilizing the Cochran-Mantel-Hanzeal test
Time Frame: 27 months
27 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain response pattern at 3 months: partial, stable or progressive pain
Time Frame: 27 months
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
27 months
Re-irradiation rate within the 6-month follow-up period
Time Frame: 27 months
27 months
Incidence of fracture at the radiation target site
Time Frame: 27 months
27 months
Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5
Time Frame: 27 months
27 months
Imaging-based local control rates at 3 and 6 months post-treatment
Time Frame: 27 months
27 months
Patient reported outcomes utilizing EORTC QLQ-C30
Time Frame: 27 months
27 months
Patient reported outcomes utilizing EORTC QLQ-BM22
Time Frame: 27 months
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Investigators

  • Study Chair: Arjun Sahgal, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
  • Study Chair: Tim Nguyen, London Regional Cancer Program, London, ON, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As per CCTG policies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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