SUPR-3D: Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases
Neoplasm Metastasis, Neoplastic Processes, Neoplasms
About this trial
This is an interventional treatment trial for Neoplasm Metastasis
Eligibility 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.
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 within 4 weeks of RT start
- 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.
Sites / Locations
- BC CancerRecruiting
- BC CancerRecruiting
- BC Cancer - Victoria
- London Health Sciences CentreRecruiting
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
SUPR (Arm 1)
VMAT rapid (Arm 2)
Planning according to local protocols. No more than 2 fields; no beam modifying devices, other than multileaf collimators (MLCs). Alternate weighting of beams allowed (ie. 1:2 AP:PA). Review of dosimetry not required, if performed as per institutional standard. Minimum of kV image matching on unit daily.
Contouring: GTV based on available imaging (CT sim scan alone-no special imaging), expect to be between 1.5cm and 20cm clinically or from imaging. CTV-optional in all scenarios. If using CTV=GTV +0.5 to 0.7cm adjust to anatomy as follows: If only bone involved: recommend not to expand past bone; but a 0.5-0.7cm CTV expansion outside of bone into muscle or soft tissue is allowed at RO discretion If bone and soft tissue involved: 0.5 to 0.7cm CTV expansion is optional, allowed at RO discretion If spinal metastases: CTV is optional. If used can include whole vertebral body at RO discretion PTV=CTV or GTV+(1 to 1.5)cm at RO discretion. PTV_eval=PTV cropped 0.5cm below skin. OARs: max 2 OARs permitted for VMAT arm. OAR constraints are at RO discretion. If lung/kidneys are within 5cm of PTV, absence of constraints for contours should be noted in treatment plans or dose constraint sheet prior to planning. PTV can be compromised for OAR at RO's discretion. Kidneys considered 1 organ