A Pilot Study of Patients With Recurrent Glioblastoma Treated With Maximal Safe Neurosurgical Resection, Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® Electronic Brachytherapy System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Patients treated with Xoft IORT device median overall survival (OS)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT for recurrent Glioblastoma. IORT using the Xoft Axxent eBx System is no worse than (non-inferior) GliaSite radiation therapy when used as stand-alone radiation treatment immediately following maximal safe neurosurgical resection in patients with recurrent glioblastoma multiforme (GBM).
详细描述
Device Description: The Xoft Axxent Electronic Brachytherapy System is a device that delivers radiation at a high dose rate. It is designed for use with Axxent applicators to treat lesions, tumors, and conditions in or on the body where radiation is indicated. The Axxent System and Applicators are FDA cleared under 510(k)s K050843, K072683, K090914 and K122951.
The purpose of this trial is to assess the overall survival of patients treated with the Xoft Axxent eBx System for single-fraction IORT following maximal neurosurgical resection of recurrent glioblastoma. A historical comparison will be made for surgical excision and GliaSite radiation therapy (Chan 2005), which resulted in a median OS of 9.1 months.
Radiation is delivered to the target tissue (adjacent to the resection margins). It avoids treatment delays and eliminates weeks of post-surgical radiation therapy during which residual cancer cells might proliferate.
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
- •Potentially-resectable, histologically proven recurrent GBM
- •Subject must be ≥ 18 years of age
- •Subject must have a Karnofsky Performance Score ≥ 70%
- •Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
- •Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
- •Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable)
排除标准
- •More than three relapses
- •Subject has multi-centric disease
- •Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor: such as:
- •Optic Chiasm
- •Optic Nerve
- •Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception
- •Subject has contraindications for MRI with or without gadolinium injections
- •Subject has contraindications for anesthesia or surgery
- •Subject is on another therapeutic clinical trial concurrently
- •Subject had previous radiation for GBM less than 3 month earlier
- •Prior history of standard dose of Central Nervous System (CNS) of more than 60 Gy
- •Intra-Operative Exclusion Criteria
- •Frozen section does not show any sign of malignant tissue
- •Dose at any organ at risk will exceed 10 Gy including:
- •Optic Nerve
结局指标
主要结局
Patients treated with Xoft IORT device median overall survival (OS)
时间窗: Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
The median and mean OS with Xoft will be calculated
The primary endpoint is Overall Survival (OS)
时间窗: Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
The primary study goal is to assess Overall Survival (OS) of subjects treated with the Xoft Axxent Electronic Brachytherapy (eBx)® System when used for single-fraction, intra-operative radiation therapy (IORT) following maximal safe neurosurgical resection of recurrent glioblastoma for patients.
次要结局
- Quality of Life Assessment (Fact-Br)(QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.)
- Radiation-related Neurotoxicity(Radiation-related Neurotoxicity will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.)
- Local Progression-free Survival (PFS)(LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.)
- Karnofsky Performance Status (KPS)(KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.)
- The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs)(UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.)