Standard Conventional RadiotherapyStereotactic Body Radiotherapy
Standard Conventional Radiotherapy: 20Gy in 5 fractions
Stereotactic Body Radiotherapy: 30 or 35Gy in 5 fractions
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Complete pain response utilizing the Cochran-Mantel-Hanzeal test — 27 months
Trial sites (11)
Facility
City
Region
Status
Arthur J.E. Child Comprehensive Cancer Centre
Calgary
Alberta
Recruiting
BCCA - Vancouver
Vancouver
British Columbia
Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
Ontario
Recruiting
Kingston Health Sciences Centre
Kingston
Ontario
Recruiting
London Health Sciences Centre Research Inc.
London
Ontario
Recruiting
Stronach Regional Health Centre at Southlake
Newmarket
Ontario
Recruiting
Odette Cancer Centre
Toronto
Ontario
Recruiting
University Health Network
Toronto
Ontario
Recruiting
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal
Quebec
Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal
Quebec
Recruiting
Hotel-Dieu de Quebec
Québec
Quebec
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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