BridgeMD
Compares treatment options for Cancer Metastatic
Official title Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
ClinicalTrials.gov ID: NCT06391242
What this study is testing
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Received systemic chemotherapy within 1 week of the protocol RT, or who are expected/planned to receive chemotherapy within one week of completing...
- Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred...
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada; Toronto, Ontario, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.