A Phase II Trial of Hypofractionated Radiotherapy (16 Gy in 2 Fractions With an Interval of One Week) for the Palliation of Complicated Bone Metastases in Patients With Poor Performance Status
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Overall pain response at the site of treatment, which will be measured at two months post-treatment. Pain response will be measured using the International Consensus on Palliative Radiotherapy Endpoints Pain Response Categories.
研究概览
简要总结
Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients with complicated bone metastases and have a low potential for severe treatment-related toxicities. There is a clear need for hypofractionated schedules in the complicated bone metastases population, especially when considering the overarching aim of palliative radiotherapy and the clinical features of this patient population. As well, current research examining hypofractionated approaches in bone metastases patients with impending or pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly scarce.
详细描述
In response the the already commented on, the purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven malignancy.
- •Patients aged 18 and above.
- •Advanced cancer patients with at least one complicated bone metastasis. A complicated bone metastasis will be operationally defined as a bone metastasis that has an accompanying: soft tissue mass or extraosseous component penetrating the normal cortical boundary; neuropathic pain; post surgical intervention for bone fixation; impending fracture or high fracture risk in weight bearing long bone as defined by Harrington's criteria but not surgical candidate: lytic bone lesion involving more than ½ the diameter of the bone cortex , greater than 2.5 cm in greatest diameter, or in the intertrochanteric line (29).
- •Patients with Karnofsky Performance Status (KPS) 30-60 at the time of baseline evaluation.
- •Patients who are planned to receive radiation treatment to the complicated site(s) being followed for study.
- •Patients who had surgery for complicated bone metastases.
- •Patients who are currently taking any systemic therapy (i.e. chemotherapy, hormone therapy, or bone modifying agents) or planning to begin systemic therapy within two weeks of treatment will be allowed to participate in the study; study personnel will note any use of systemic therapy in the study records.
- •Patients who are able to provide a worst pain score at the complicated site(s) being followed for study.
- •Patients who are able and willing to fill out a daily diary.
- •Patients who are able to provide informed consent prior to being enrolled to the study.
排除标准
- •Patients with leukemia or Hodgkin's/non-Hodgkin's lymphoma.
- •Patients who are surgical candidates with pathologic fractures or lesions at high risk for pathologic fracture in the humerus, radius, ulna, femur, tibia, or fibula. They will be eligible for post-operative hypofractionated radiotherapy.
- •Patients with spinal cord compression or cauda equina syndrome.
- •Patients who are currently receiving any radiopharmaceuticals.
- •Patients who are unable to record a pain score, complete a daily diary or to communicate requested information to study personnel.
研究组 & 干预措施
Radiotherapy in bone metastases
The purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall pain response at the site of treatment, which will be measured at two months post-treatment. Pain response will be measured using the International Consensus on Palliative Radiotherapy Endpoints Pain Response Categories.
时间窗: 2 months after the end of the second radiotherapy fraction
The general follow up will finish 1 year after each patient inclusion
次要结局
- Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22(General follow up will be 1 year after each patient inclusion)
- Side effects of Radiotherapy.(General follow up will be 1 year after each patient inclusion)
研究者
Mauricio F Silva
Medical Doctor at Radiation Oncology Unity
Santa Casa de Porto Alegre