NCT03831243已完成不适用
A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
Cancer Research Antwerp2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年4月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Pain response
研究概览
简要总结
This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). The primary aim of this trial is to double the complete response rate. Secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, HRQoL through patient-reported outcome measures (PROMs), pain flare, and re-irradiation need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 confirmed malignancy.
- •Pain score ≥ 2 on a scale from 0 to
- •Radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain.
- •Lesions ≤ 5cm in largest diameter.
- •Per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below.
- •No more than 3 painful lesions needing treatment.
- •Life expectancy estimated at > 3 months.
- •Patients who have received the information sheet and signed the informed consent form.
- •Patients must be willing to comply with scheduled visits, treatment plan, and other study procedures.
- •Patients with a public and/or private health insurance coverage.
排除标准
- •Bone metastasis in previously irradiated sites.
- •Previous radioisotope treatment for bone metastases.
- •Complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression [16].
- •Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study.
- •Individual deprived of liberty or placed under guardianship.
结局指标
主要结局
Pain response
时间窗: 4 weeks after RT visit
Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.
次要结局
- Re-irradiation need(2 years after radiotherapy)
- Acute toxicity Measured with CTCAE version 5.0(3 months after radiotherapy)
- Late toxicity Measured with CTCAE version 5.0(2 years after radiotherapy)
- Incidence of pain flare(24-48 hours after radiotherapy)
- Duration of pain response(2 years after radiotherapy)
- Impact of treatment on Quality of Life: EORTC quality of life questionnaire (QLQ) BM22(2 years after radiotherapy)
- Number of Subsequent Serious Skeletal events(2 years after radiotherapy)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)InfertilityNCT02047227Merck KGaA, Darmstadt, Germany939
尚未招募
3 期
Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in IslamabadSARS-CoV-2NCT05428592AIM Vaccine Co., Ltd.1,100
Unknown
3 期
Stroke and Tocotrienol: Unique Role in NeuroprotectionIschemic StrokeNCT02263924Seberang Jaya Clinical Research Centre150
招募中
2 期
Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast CancerOptical Surface Monitoring TechnologyLarge-segment RadiotherapyBreast CancerNCT05804916Peking Union Medical College Hospital556
招募中
3 期
AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic CancerBorderline Resectable Pancreatic CancerLocally Advanced Pancreatic AdenocarcinomaNCT04617821Fudan University300