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)
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
20Gy in 5 fractions
30 or 35Gy in 5 fractions
Kingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGLondon Health Sciences Centre Research Inc.
London, Ontario, Canada
RECRUITINGStronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada
RECRUITINGOdette Cancer Centre
Toronto, Ontario, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITINGCHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
RECRUITINGHotel-Dieu de Quebec
Québec, Quebec, Canada
RECRUITINGComplete pain response utilizing the Cochran-Mantel-Hanzeal test
Time frame: 27 months
Pain response pattern at 3 months: partial, stable or progressive pain
Time frame: 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
Re-irradiation rate within the 6-month follow-up period
Time frame: 27 months
Incidence of fracture at the radiation target site
Time frame: 27 months
Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5
Time frame: 27 months
Imaging-based local control rates at 3 and 6 months post-treatment
Time frame: 27 months
Patient reported outcomes utilizing EORTC QLQ-C30
Time frame: 27 months
Patient reported outcomes utilizing EORTC QLQ-BM22
Time frame: 27 months
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