Scholarlink

Background <p>Bone metastases cause significant pain and functional limitation. Conventional external beam radiotherapy (EBRT) provides effective symptom relief, but local progression remains frequent. Stereotactic body radiotherapy (SBRT) offers improved local control but is often resource-intensive and associated with higher vertebral compression fracture (VCF) rates. Integrating a simultaneous gross tumour volume (GTV) boost within a conventional EBRT regimen may provide a feasible and safe alternative.</p> Methods <p>This is a prospective, multicentre, multinational, single-arm study enrolling 100 adults with painful bone metastases from solid tumours. Eligible patients receive 20&#xa0;Gy in 5 fractions with a 5&#xa0;Gy “stereotactic-lite” GTV boost (total 25&#xa0;Gy) or 30&#xa0;Gy in 10 fractions with a 6&#xa0;Gy boost (total 36&#xa0;Gy), delivered using intensity modulated radiotherapy or volumetric modulated arc therapy. The primary endpoints are feasibility (commencement of radiotherapy within 10 working days of computed tomography simulation in at least 80% of patients) and safety (incidence of Common Terminology Criteria for Adverse Events version 5.0 grade ≥ 2 acute toxicity within 3 months). Secondary endpoints include pain response, radiation site-specific progression-free survival, rates of VCF and long bone fracture, skeletal-related events, quality of life changes via EORTC QLQ-C30 and BM22, and overall survival.</p> Discussion <p>This protocol evaluates a hybrid EBRT approach with a simultaneous integrated boost as a practical strategy to enhance local tumour control and symptom relief without delaying palliation. If feasible and safe, this approach may bridge the gap between conventional EBRT and SBRT.</p> Trial registration <p>Australian and New Zealand Clinical Trial Registry (ACTRN12625000615482).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Study protocol: feasibility and safety of conventional external-beam radiotherapy with an integrated stereotactic lite gross-tumour-volume boost for painful bone metastases: the HYBRID study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月10日

查看全文
  • Shing Fung Lee,
  • Ee Siang Choong,
  • John Leung,
  • Tee Lim,
  • Sagar Ramani,
  • Daryl Lim Joon,
  • Craig Macleod,
  • Jonathan Mark Tomaszewski,
  • Jeremy Chee Seong Tey,
  • Farshad Foroudi,
  • Michael Chao

摘要

Background

Bone metastases cause significant pain and functional limitation. Conventional external beam radiotherapy (EBRT) provides effective symptom relief, but local progression remains frequent. Stereotactic body radiotherapy (SBRT) offers improved local control but is often resource-intensive and associated with higher vertebral compression fracture (VCF) rates. Integrating a simultaneous gross tumour volume (GTV) boost within a conventional EBRT regimen may provide a feasible and safe alternative.

Methods

This is a prospective, multicentre, multinational, single-arm study enrolling 100 adults with painful bone metastases from solid tumours. Eligible patients receive 20 Gy in 5 fractions with a 5 Gy “stereotactic-lite” GTV boost (total 25 Gy) or 30 Gy in 10 fractions with a 6 Gy boost (total 36 Gy), delivered using intensity modulated radiotherapy or volumetric modulated arc therapy. The primary endpoints are feasibility (commencement of radiotherapy within 10 working days of computed tomography simulation in at least 80% of patients) and safety (incidence of Common Terminology Criteria for Adverse Events version 5.0 grade ≥ 2 acute toxicity within 3 months). Secondary endpoints include pain response, radiation site-specific progression-free survival, rates of VCF and long bone fracture, skeletal-related events, quality of life changes via EORTC QLQ-C30 and BM22, and overall survival.

Discussion

This protocol evaluates a hybrid EBRT approach with a simultaneous integrated boost as a practical strategy to enhance local tumour control and symptom relief without delaying palliation. If feasible and safe, this approach may bridge the gap between conventional EBRT and SBRT.

Trial registration

Australian and New Zealand Clinical Trial Registry (ACTRN12625000615482).