No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
Canadian Cancer Trials Group · Research network
Who this trial is looking for
This trial is looking for patients with painful bone cancer. Participants will receive treatment to see if a newer type of radiation therapy helps with pain relief better than the standard treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed solid tumor.
I have a painful non-spine bone metastasis.
I have a pain score of at least 2 related to my cancer.
My doctor expects me to live more than 6 months.
I am stable and do not plan to change my pain medications.
My performance status is between 0 and 2.
I have signed a consent form to participate.
You may not be able to join if
I have bone metastases in my hands, feet, skull, or spine.
My bone cancer is from small cell or germ cell origin.
I received radionuclide therapy within the last 30 days.
I have had prior radiation therapy to the painful bone metastasis site.
I received chemotherapy within the last week.
I have an unstable fracture at the painful bone site.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 con…
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)
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
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
…
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.
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