Phase II Study of Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients With Gastrointestinal Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain relief rate
研究概览
简要总结
Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis.
The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone.
Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radiologic detectable bone metastasis (spine or non-spine)
- •Patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc.
- •Patients over 20 years of age of both genders
- •ECOG: 0 ~ 2
- •Pain: worst pain score on BPI ≥3
排除标准
- •Undetectable bone metastasis on radiologic study
- •Patients who have previous surgery history at same site
- •Patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture
- •Patients who have hypersensitivity for zoledronic acid or other bisphosphonate
- •Patients who have treatment history with zoledronic acid or other bisphosphonate
- •Abnormal renal function or history of kidney transplantation
- •Patients with metabolic bone disease
- •Synchronous symptomatic brain metastasis
- •Women who are pregnant, breast-feeding, or possible pregnancy
研究组 & 干预措施
RT & Zoledronic acid
Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions, Zoleronic acid: every 4 weeks, 6 times, 4.0 mg iv
干预措施: Zoledronic acid (Drug)
RT & Zoledronic acid
Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions, Zoleronic acid: every 4 weeks, 6 times, 4.0 mg iv
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Pain relief rate
时间窗: Change from baseline pain extent at 1,3,6 months
次要结局
- skeletal related events (fracture and spinal cord compression)(at 18months after the IRB approval)
- Overall survival(at 18months after the IRB approval)
研究者
Jinsil Seong
Professor in Dept. of Radiation Oncology
Severance Hospital