Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Retreatment rate at 6 months
研究概览
简要总结
Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;
- •Age between 18 and 85 years old;
- •Performance on the ECOG scale less than or equal to
- •Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.
排除标准
- •Refusing to sign or inability to understand the consent term;
- •Pain less than 2/10 on the numeric pain rating scale;
- •Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;
- •Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position;
- •Previous cancer and previous oncological treatments;
- •Previous autoimmune diseases, even if controlled;
- •Current pregnancy.
结局指标
主要结局
Retreatment rate at 6 months
时间窗: 6 months after radiotherapy
Percentage of patients that needed a second corse of radiation for painful bone lesions
次要结局
- Overall survival(12 months)
- Pain flair incidence(1, 3, 6 and 12 months)
- Pain relief by the numerical rating pain scale(1, 3, 6 and 12 months)
- Local control(6 months and 12 months)
- Progression-free survival(12 months)
- Bone event-free survival(6 months)
- Quality of life by EORCT QLQ-C30(1, 6 and 12 months)
- Quality of life by EORCT QLQ-C30 and MY-24(1, 6 and 12 months)
研究者
Geovanne Pedro Mauro
Primary Investigator
Instituto do Cancer do Estado de São Paulo