Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.
详细描述
Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of the tumor prior to initiating radiation therapy.
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 with radiographic evidence of suggestive of a primary high-grade glioma
- •Brain MRI with contrast demonstrates an enhancing mass within 60 days prior to registration. Patient must be deemed a candidate for LITT from MRI by Neurosurgery in order to be eligible.
- •History and physical including neurological exam within 30 days prior to registration
- •Karnofsky performance status ≥50% within 30 days prior to registration
- •Age ≥ 18 years old
- •Patients must have signed an approved informed consent
- •Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
- •Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.
排除标准
- •Patients that are not surgical candidates for stereotactic biopsy or laser ablation
- •Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •History or presence of serious uncontrolled ventricular or significant arrhythmias.
- •Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
- •Infratentorial tumor or evidence of leptomeningeal spread
- •Inability to undergo a MRI
- •Pregnant or breast-feeding women
研究组 & 干预措施
LITT with Hypofractionated RT
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.
干预措施: LITT (Procedure)
LITT with Hypofractionated RT
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.
干预措施: Hypofractionated Radiation Therapy (Radiation)
结局指标
主要结局
Adverse Events
时间窗: 2 years
The ability to complete protocol treatment (i.e. LITT and radiation therapy) without undue treatment-related acute toxicity as defined below: * Safety: \< 40% rate of irreversible Grade 3 or higher neurologic treatment-related toxicity * Early stopping rules: Two or more Grade 2 or higher symptomatic CNS hemorrhages; Eight treatment-related Grade 3 or higher non-hematologic or Grade 4 or higher hematologic treatment related toxicities
次要结局
- Median progression-free survival(2 years)
- Median overall survival(2 years)
- 1-year overall survival(1 year)
- Quality of Life assessed by M.D. Anderson Symptom Inventory(2 years)
- Progression-free survival at 6 months(6 months)
- Overall response rate(2 years)
研究者
Department of Radiation Oncology
Principal Investigator
University of Maryland, Baltimore