SUPR-3D: Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases

Launched by BRITISH COLUMBIA CANCER AGENCY · Oct 1, 2018

Keywords

ClinConnect Summary

The SUPR-3D clinical trial is comparing two types of radiation therapy for patients who have cancer that has spread to their bones. The main goal is to see how these treatments affect patients' quality of life, specifically in controlling nausea and vomiting that can happen after radiation therapy. The two treatments being studied are standard palliative radiotherapy and a newer method called VMAT. While the researchers expect both treatments to help with pain in similar ways since they deliver the same amount of radiation, they want to find out if one method is better than the other for managing these side effects.

To participate in this trial, patients must be at least 18 years old and have a diagnosis of cancer with bone metastases, meaning the cancer has spread to the bones. Eligible patients should also be able to complete quality of life questionnaires and be available for follow-up care. This trial is currently recruiting participants, and those who join can expect to receive radiation therapy while also helping researchers understand how these treatments affect their daily lives. It's important for potential participants to know that they will receive care and support throughout the study.

Gender

ALL

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.
• • 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.