Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain.
详细描述
Primary Objective:
To determine the feasibility of enrollment and treatment of patients within MD Anderson Cancer Center with SRS hypophysectomy to plan future trials. Feasibility will be defined as completion of SRS hypophysectomy enrollment and treatment of the lead-in cohort (n=20 patients) within one year of trial activation.
Secondary Objectives:
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the worst pain subscale of the Brief Pain Inventory (BPI) short form.57
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the pain composite scale of the BPI short form.57
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years old on the day of signing informed consent and willing and able to sign a written informed consent.
- •English fluency in order to complete PROs and neurocognitive assessment
- •Pathologic or cytologic confirmation of malignancy.
- •Poorly controlled intractable nociceptive or mixed pain limiting function or quality of life. Participants must have exhausted or not a candidate for standard of care pain control measures such as opioids, injections/ablations, conventional radiation therapy, or surgical intervention with a curative intent and pain limiting function that affects the participants quality of life in the judgment of the treating physician. Refractory status will require at least consultation and two follow-up visits with pain specialists (pain management or supportive care).
- •ECOG performance status of 0-
- •Life expectancy is greater than 4 weeks and less than 1 year in the treating physician's judgment.
排除标准
- •Participants with prior cranial or head/neck radiation where cumulative organ-at-risk dose constraints cannot be achieved (see section 4.2).
- •Inability to have an MRI of the brain for reasons such as a non-compatible bioimplant that could be displaced during MRI, shrapnel embedded (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes).
- •Expressions of pain due to depression, delirium or addictive behavior
- •Participants who are pregnant.
- •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study in the judgment of the Investigators.
研究组 & 干预措施
SRS hypophysectomy
Once the radiation plan is ready, you will be brought to the radiation treatment room and positioned for treatment. You will be lying on your back on the treatment table during the radiation treatment. You will not see, hear, or feel the radiation during the treatment. The treatment time varies but may range from 1-3 three hours. Once the treatment is completed, the headframe/mask will be removed and you will be brought to a recovery area.
干预措施: Stereotactic Radiosurgery (Device)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点