Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas
概览
- 阶段
- 不适用
- 干预措施
- Intensity-Modulated Radiation Therapy
- 疾病 / 适应症
- Glioblastoma
- 发起方
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of wound infection or wound dehiscence
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
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. III. To determine the effect on quality of life (QoL) using European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). TERTIARY OBJECTIVES: I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in the coronal plane in T-1W magnetic resonance (MR) images.
研究者
入排标准
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
Treatment (IM-SRT)
Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
干预措施: Quality-of-Life
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)