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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Conventional Radiotherapy | Active Comparator |
| |
| Stereotactic Body Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Conventional Radiotherapy | Radiation | 20Gy in 5 fractions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete pain response utilizing the Cochran-Mantel-Hanzeal test | 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Parulekar | Contact | 613-533-6430 | wparulekar@ctg.queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BCCA - Vancouver | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
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| Stereotactic Body Radiotherapy |
| Radiation |
30 or 35Gy in 5 fractions |
|
| 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 |
| Imaging-based local control rates at 3 and 6 months post-treatment | 27 months |
| Patient reported outcomes utilizing EORTC QLQ-C30 | 27 months |
| Patient reported outcomes utilizing EORTC QLQ-BM22 | 27 months |
| Juravinski Cancer Centre at Hamilton Health Sciences | Not yet recruiting | Hamilton | Ontario | L8V 5C2 | Canada |
|
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
|
| London Health Sciences Centre Research Inc. | Recruiting | London | Ontario | N6A 5W9 | Canada |
|
| Stronach Regional Health Centre at Southlake | Recruiting | Newmarket | Ontario | L3Y 2P9 | Canada |
|
| Odette Cancer Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| CHUM-Centre Hospitalier de l'Universite de Montreal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
|
| Hotel-Dieu de Quebec | Recruiting | Québec | Quebec | G1R 2J6 | Canada |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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