NCT07202273招募中不适用
A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the rate at which the intervention is delivered with fidelity to protocol.
研究概览
简要总结
The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.
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
- •Participant aged ≥ 18 years.
- •Diagnosis of any cancer with one to two sites of painful and treatable metastatic bone lesions.
- •Bone metastases are causing pain or instability in the opinion of the treating investigator.
- •Amenable to single fraction radiation therapy per the discretion of the treating physician.
- •CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
- •ECOG Performance Status ≤
- •Participants must adhere to the following sex and contraceptive/barrier requirements:
- •If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy test are available for review before treatment.
- •For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
- •< 50 years of age:
- •Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- •Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- •--≥ 50 years of age:
- •Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- •Had radiation-induced menopause with last menses >1 year ago; or
- •Had chemotherapy-induced menopause with last menses >1 year ago
- •Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Evidence of spinal cord compression caused by the bone metastases to be treated.
- •Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- •Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- •Participants taking prohibited medications as described in Section 6.7.1.
研究组 & 干预措施
Simulation-free, single-fraction palliative radiation therapy
Experimental
干预措施: simulation-free, single-fraction palliative radiation therapy (Radiation)
结局指标
主要结局
To assess the rate at which the intervention is delivered with fidelity to protocol.
时间窗: 1 day
To provide proof-of-concept that patients can be treated with simulation-free, single-fraction palliative radiation therapy with only a single in-person visit to Huntsman Cancer Hospital (HCH). This will be defined as receiving simulation-free, single-fraction radiation therapy with documented real-time approval by the radiation oncologist, medical physicist, and radiation therapist that the treatment adequately covers the target without unreasonable or unsafe differences.
次要结局
- The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline.(30 days)
研究者
研究点 (1)
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