Recruiting
Phase 3

Stereotactic Body Radiotherapy vs. Conventional Palliative Radiotherapy

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06391242

Conditions

Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Conventional Radiotherapy

Stereotactic Body Radiotherapy

Study Details

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

Study ID

NCT06391242

Start date

Mar 7, 2025

Status verified date

Jan, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Conventional Radiotherapy

experimental: Stereotactic Body Radiotherapy

Interventions

Standard Conventional Radiotherapy

20Gy in 5 fractions

Stereotactic Body Radiotherapy

30 or 35Gy in 5 fractions

Primary outcome measure

  • Complete pain response utilizing the Cochran-Mantel-Hanzeal test [ Time Frame: 27 months ]

Central Contacts and Locations

Central contacts

Wendy Parulekar

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

Locations

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Marc Kerba

403 521-3164

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Emma Dunne

604 877-6000

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Anand Swaminath

905 387-9495

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Timothy Nguyen

519 685-8600

Stronach Regional Health Centre at Southlake

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Zahra Kassam

905 895-4521

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Alexander Louie

416 480-4951

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Chiaojung Jillian Tsai

416 946-4501

CIUSSS de l'Est-de-I'lle-de-Montreal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Peter Vavassis

514 252-3425

CHUM-Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Giuseppina Laura Masucci

514 890-8254

Hotel-Dieu de Quebec

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Isabelle Thibault

418 691-5181

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Aug 11, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-08-11.