Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 7
- 主要终点
- Safety as assessed by number of participants experiencing adverse events
研究概览
简要总结
The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases
详细描述
The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy.
Primary Objective:
To evaluate improvement of complete pain response rate in painful non-spine bone metastases and painful non-bone metastases with dose escalated radiation using a ten fraction radiation regimen
Secondary Objectives:
To evaluate best pain response To evaluate mean pain scores To evaluate the duration of pain response To evaluate the changes in quality-of-life following radiation To evaluate the rates of retreatment with radiation secondary to disease or symptom progression To evaluate treatment related toxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Have provided signed informed consent for the trial
- •Aged ≥18 years at the time of informed consent
- •Histologic proof of malignancy
- •Radiologic or histologic evidence of bone metastases or non-bone metastases
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3
- •Pain Score ≥ 3
- •Life expectancy of six months or more
- •Willing and able to comply with all aspects of the protocol
- •A female participant is eligible to participate if she is not pregnant and not breastfeeding
- •Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- •A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment.
排除标准
- •Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)
- •Spinal metastasis
- •Active compression of spinal cord/cauda equina
- •Previous RT or SBRT to the same site
- •> 3 sites requiring radiation treatment
研究组 & 干预措施
Therapeutic benefit
Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.
Palliative radiation dose escalation
The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.
干预措施: EXTERNAL BEAM RADIATION (Biological)
结局指标
主要结局
Safety as assessed by number of participants experiencing adverse events
时间窗: One month
Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)
次要结局
- Severity as assessed by number of participants experiencing toxicity and adverse events(One month)
研究者
Matthew Pierre Deek
Assistant Professor, Radiation Oncology
Rutgers, The State University of New Jersey