Comparing simple palliative radiotherapy to advanced 3D conformal radiotherapy for bone metastases
SUPR-3D: A Randomized Phase III Trial Comparing Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases
This study is testing whether a simpler type of radiation therapy can help people with bone metastases feel just as good as a more advanced method while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Drugs / interventions | Radiation |
| Locations | 5 sites (Prince George, British Columbia and 4 other locations) |
| Trial ID | NCT03694015 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of simple unplanned palliative radiotherapy (SUPR) versus 3D conformal radiotherapy (VMAT) in patients with bone metastases. The primary focus is on patient-reported quality of life related to the control of radiation-induced nausea and vomiting (RINV). Participants will receive either treatment approach, with the hypothesis that pain response will be similar due to equivalent dosing. The study aims to determine if the simpler SUPR technique can provide comparable benefits to the more complex VMAT method while minimizing adverse effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a clinical diagnosis of cancer and bone metastases who are receiving palliative radiotherapy.
Not a fit: Patients who do not have bone metastases or those who are not receiving palliative radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients undergoing palliative treatment for bone metastases by optimizing radiation therapy techniques.
How similar studies have performed: Previous studies have shown varying success with different radiotherapy techniques, but this specific comparison of SUPR and VMAT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Able to provide informed consent * Clinical diagnosis of cancer with bone metastases (biopsy not required) * Currently being managed with palliative intent RT to 1-3 RT fields for bone metastases, at least one RT field (PTV) must (at least) partly lie within T11-L5 or pelvis. * ECOG Performance Status 0-3 * Patient has been determined to potentially benefit from 8 Gy or 20 Gy * Radiation Oncologist is comfortable prescribing 8 Gy in 1 fraction or 20 Gy in 5 fractions RT for bone metastases * Negative pregnancy test result for women of child-bearing potential * The baseline assessment must be completed within required timelines, prior to randomization. * Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * For simplicity of planning, expected GTV should be less than 20 cm based on radiological or clinical evidence * Patient must be prescribed a 5-HT3 receptor antagonist (e.g. Ondansetron) as antiemetic prophylaxis prior to RT start. * Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study, via paper or using PatientPortals.ca or REDCap if they provide their email address on the informed consent Exclusion Criteria: * Serious medical co-morbidities precluding radiotherapy * Clinical evidence of spinal cord compression * Spinal cord in treatment field has already received at least \>30 Gy EQD2 * Whole brain radiotherapy (WBRT) within 4 weeks of RT start or planned WBRT in the first 4 weeks after last RT * Solitary plasmacytoma * Pregnant or lactating women * Target volume cannot be encompassed by a single VMAT isocentre * Custom mould room requirements (shells and other immobilization that is standard-of-care is acceptable) * Greater than two organs-at-risk requiring optimization. * Patients requiring treatments outside standard clinical hours * Implanted electronic device within 10 cm of the RT fields * Prostheses in the axial plane of the target, or within 1 cm of the PTV out-of-plane * Previous RT that requires an analysis of cumulative dose (i.e. sum plans or EQD2 calculations) * Oral or IV contrast if the local standard-of-care requires compensation for this in planning.
Where this trial is running
Prince George, British Columbia and 4 other locations
- BC Cancer — Prince George, British Columbia, Canada (Recruiting)
- BC Cancer — Vancouver, British Columbia, Canada (Recruiting)
- BC Cancer - Victoria — Victoria, British Columbia, Canada (Terminated)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Rob Olson, MD — British Columbia Cancer Agency
- Study coordinator: Hadassah Abraham
- Email: hadassah.abraham@bccancer.bc.ca
- Phone: 250-645-7300
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.