NCT06391242 Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
| NCT ID | NCT06391242 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Canadian Cancer Trials Group |
| Condition | Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2025-03-07 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 230 participants in total. It began in 2025-03-07 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 * 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.
Contact & Investigator
Arjun Sahgal
STUDY CHAIR
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Frequently Asked Questions
Who can join the NCT06391242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06391242 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 230 participants.
Is NCT06391242 currently recruiting?
Yes, NCT06391242 is actively recruiting participants. Contact the research team at wparulekar@ctg.queensu.ca for enrollment information.
Where is the NCT06391242 trial being conducted?
This trial is being conducted at Kingston, Canada, London, Canada, Newmarket, Canada, Toronto, Canada and 3 additional locations.
Who is sponsoring the NCT06391242 clinical trial?
NCT06391242 is sponsored by Canadian Cancer Trials Group. The principal investigator is Arjun Sahgal at Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. The trial plans to enroll 230 participants.
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