Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

Launched by CANADIAN CANCER TRIALS GROUP · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring two different types of radiation therapy for patients with painful bone metastases, which means cancer that has spread to the bones. The study aims to find out whether Stereotactic Body Radiation Therapy (SBRT), which delivers high doses of radiation precisely to the painful area while protecting surrounding healthy tissue, is more effective for pain relief compared to Conventional Radiation Therapy (CRT), which treats the painful area but may also affect nearby healthy parts.

To participate in this trial, individuals must be between the ages of 65 and 74 and have a confirmed diagnosis of solid tumor cancer with a specific painful bone metastasis causing a minimum pain score of 2. Other criteria include having an expected survival of over six months and stable pain management. Participants will receive either type of radiation therapy and will be monitored for their pain relief and overall experience. It’s important to note that those with certain types of metastases, recent treatments, or specific health conditions may not be eligible for this trial.

Gender

ALL

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 and spine (including sacrum).
• • 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.