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

NCT06391242 | Recruiting Phase 3 DMC

• 1 other identifier: SC29
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 7

Brief 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 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)

Conditions

Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Complete pain response utilizing the Cochran-Mantel-Hanzeal test

  27 months

Secondary Outcomes (8)

• Pain response pattern at 3 months: partial, stable or progressive pain

  27 months

• Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);

  27 months

• Re-irradiation rate within the 6-month follow-up period

  27 months

• Incidence of fracture at the radiation target site

  27 months

• Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5

  27 months

Study Arms (2)

Standard Conventional Radiotherapy

ACTIVE COMPARATOR

Radiation: Standard Conventional Radiotherapy

Stereotactic Body Radiotherapy

EXPERIMENTAL

Radiation: Stereotactic Body Radiotherapy

Interventions

Standard Conventional Radiotherapy RADIATION

20Gy in 5 fractions

Standard Conventional Radiotherapy

Stereotactic Body Radiotherapy RADIATION

30 or 35Gy in 5 fractions

Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead

Study Sites (7)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

RECRUITING

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Arjun Sahgal

  Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

  STUDY CHAIR

• Tim Nguyen

  London Regional Cancer Program, London, ON, Canada

  STUDY CHAIR

Central Study Contacts

Wendy Parulekar

CONTACT

613-533-6430; wparulekar@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 30, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)