RecruitingACTRN12625000615482

The Feasibility and Safety of Conventional external beam radiation therapy (EBRT) and Integrated Stereotactic Gross Tumour Volume (GTV) Boost in Bone Metastases

The feasibility and safety of conventional EBRT and integrated stereotactic-lite GTV boost in bone metastases in participants with solid tumour

Sponsor

GenesisCare

Enrollment

100 participants

Start Date

Jun 25, 2025

Study Type

Interventional

Conditions

Bone Metastases

Summary

This study aims to test a new way to deliver radiation therapy to people with cancer that has spread to their bones to enhance local control of metastatic lesions while maintaining acceptable toxicity profiles. Who is it for? You may be eligible to join this study if you are aged 18 years and older, are with Pathological diagnosis of a solid tumour, no planned change to main medication on the first day of protocol radiotherapy. You must have a imaging confirmed bone metastases, estimated life expectancy greater than 3 months. Study details All participants who meet the eligibility criteria in this study will be given either: once a day for 5 days over 1 week, or once a day for 10 days over 2 weeks (Monday to Friday, with weekends off unless needed). The treatment includes a standard radiation dose to the affected bone area, along with a more focused, higher-dose boost to the main tumour area using advanced imaging. This boost is designed to better target the cancer while protecting healthy tissue. During and after completion of the treatment participants will be assessed for pain response and patient outcomes using questionnaires, fractures using imaging, and need for reirradiation and salvage surgery to treatment sites through clinical follow-up and medical record review. It is hoped that this research project will help determine if this combined approach is safe, effective, and practical to deliver in routine care to improve pain relief and tumour control while keeping side effects low

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria11

Aged 18 years or older (21 years or older in Singapore).
Pathological diagnosis of a solid tumour (excluding germ cell tumours and small-cell cancers).
No planned change to pain medication on the first day of protocol radiotherapy.
Imaging-confirmed bone metastases on standard imaging (X-ray, WBBS, CT, MRI, or PET).
Pain score greater than or equal to 2 on the modified Brief Pain Inventory.
Estimated life expectancy greater than 3 months.
ECOG performance status of 0 to 2.
Ability to complete pain and quality of life assessments.
If treating the axial spine: at least 3 contiguous vertebral body segments involved.
Gross tumour volume (GTV) boost size must be greater than 1 cm.
A maximum of 3 GTV boost sites permitted.

Exclusion Criteria8

Prior radiotherapy or surgery to the intended treatment site.
Symptomatic spinal cord compression or cauda equina syndrome.
Spinal Instability Neoplastic Score (SINS) greater than 12.
Vertebral compression fracture with greater than 50% height loss or bony retropulsion (if spine is treated).
Mirels’ score greater than 9 for long bone metastases (if non-spinal bone is treated).
Systemic chemotherapy within 1 week before or after protocol radiotherapy.
Inability to provide informed consent.
Pregnant or breastfeeding.

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Interventions

The HYBRID study is a prospective, multi-site clinical trial evaluating the feasibility and safety of combining conventional external beam radiation therapy (EBRT) with an integrated stereotactic LiTe (Low-intensity Targeted) Gross Tumour Volume (GTV) boost in patients with bone metastases from solid tumours. The intervention aims to enhance local control of metastatic lesions while maintaining acceptable toxicity profiles. All participants will receive standard radiation treatment, which helps relieve pain and control the cancer. In this study, the radiation schedule will be at the discretion of by the treating Doctor as to the best treatment for the individual patient. This schedule will be in one of 2 ways either: once a day for 5 days over 1 week, or once a day for 10 days over 2 weeks (Monday to Friday, with weekends off unless needed). The treatment includes a standard radiation dose to the affected bone area, along with a more focused, higher-dose boost to the main tumour area using advanced imaging. advanced imaging technique. CT Scan (Computed Tomography) is used to support the planning and delivery of conventional external beam radiation therapy (EBRT) along with the higher-dose boost. This boost is designed to better target the cancer while protecting healthy tissue. The Radiation treatment will be administered a radiation therapist. Depending on the schedule: The 1-week option delivers 20 units of radiation (called Gray or Gy) to the broader area, with a focused boost of 25 Gy. The 2-week option delivers 30 Gy to the broader area, with a focused boost of 36 Gy. The goal is to see if this combined approach improves cancer control in the bones while keeping side effects low. Adherence to the delivery of radiation treatment will be via data collected and reviewed with patient medical records.