Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of wound infection or wound dehiscence
研究概览
简要总结
This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the incidence of wound infection (requiring oral/intravenous [IV] antibiotics or surgery), or wound dehiscence.
SECONDARY OBJECTIVES:
I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning.
II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.
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
- •Patients must have histologically confirmed low or high grade glioma (grade II-IV)
- •Karnofsky performance status (KPS) >= 60
- •Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment
- •Estimated survival >= 3 months
- •Labs considered acceptable per standard of care
- •Patient must sign a study specific informed consent form
- •Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery
排除标准
- •Prior history of scalp radiation or intolerance to standard course of radiation treatment
- •Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use)
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Karnofsky performance status (KPS) < 60
- •Patient can't have magnetic resonance imaging (MRI) scan
- •Active collagen vascular disease
研究组 & 干预措施
Treatment (IM-SRT)
Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Treatment (IM-SRT)
Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
干预措施: Quality-of-Life (Other)
结局指标
主要结局
Incidence of wound infection or wound dehiscence
时间窗: Up to 2 years
Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.
次要结局
- Incidence of titanium implants(Up to 2 years)
- Incidence of hair loss(Up to 2 years)
- Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire(Up to 2 years)
- Incidence of recovery rate(Up to 2 years)