Comparing two types of radiation therapy for painful bone metastases
A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Participants With Painful Non-Spine Bone Metastases
This study is testing whether a new type of radiation therapy can help people with painful bone cancer feel better than the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canadian Cancer Trials Group Research network |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Kingston, Ontario and 6 other locations) |
| Trial ID | NCT06391242 on ClinicalTrials.gov |
What this trial studies
This phase III randomized controlled trial aims to compare Stereotactic Body Radiation Therapy (SBRT) with conventional palliative radiation therapy (CRT) in patients suffering from painful non-spine bone metastases. The study will enroll 230 participants who will receive either SBRT or CRT over five treatment sessions. Participants will be monitored for pain relief and radiological progression at 3 and 6 months post-treatment. The goal is to determine which treatment provides better pain management while minimizing damage to surrounding healthy tissues.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed solid tumors and a dominant painful non-spine bone metastasis with a minimum pain score of 2.
Not a fit: Patients with metastases in the hands, feet, cranium, spine, or those who have received prior radiation therapy to the affected area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain relief for patients with painful bone metastases.
How similar studies have performed: Previous studies have shown promising results for SBRT in treating bone metastases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kingston, Ontario and 6 other locations
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- London Health Sciences Centre Research Inc. — London, Ontario, Canada (Recruiting)
- Stronach Regional Health Centre at Southlake — Newmarket, Ontario, Canada (Recruiting)
- Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (Recruiting)
- Hotel-Dieu de Quebec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Wendy Parulekar
- Email: wparulekar@ctg.queensu.ca
- Phone: 613-533-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.