Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Assessment of Neurocognitive Function
研究概览
简要总结
Butterfly glioblastomas (bGBM), defined as tumours crossing the midline to involve hemispheres bilaterally, have a dismal prognosis with a median survival of 3.3-6 months and only 9% of patients with bGBM survive 2-years. These figures put bGBM in the worst end of the spectrum of GBM prognosis, significantly inferior to the survival figures quoted in the literature with standard of care - 14.6 months - particularly when 5-aminolevulinic acid is used as surgical adjuvant - 17.47 months.
Despite the poor outcome of this disease, there is preliminary evidence suggesting that active oncology treatment can impact the survival of patients with this condition.With particular regards to surgical resection versus biopsy, there is a suggestion that resection improves overall survival at 6 months with no clear difference at 12 and 18 months of follow up.
Laser-induced thermal therapy (LITT) is a minimally invasive laser ablation technique used in a range of brain tumours, including glioblastomas, with similar overall survival to the ones reported for open surgery in patients with lesions not amenable to open resection. The minimally invasive nature of this technique, significantly reducing the collateral damage to the surrounding brain structures, suggests Its potential in the treatment of this bGBM [14] with significant implications as a deficit-sparing technique, particularly if associated with preoperative and intraoperative monitoring and mapping techniques.
The SLITT-GBM study will combine unilateral open surgery for maximal tumour resection with contralateral LITT to the smaller component/residual.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presumptive diagnosis of bGBM as per preoperative MRI and MDT assessment
- •Presumed residual / smaller component of the bGBM has to be < 2.5cm
- •Performance Status 0-1
- •Able to consent for the study
排除标准
- •bGBM measuring >2.5 cm in both hemispheres.
- •Tumour progression between surgical debulking and LITT treatment
- •Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)
研究组 & 干预措施
Surgical resection followed by LITT
Combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.
干预措施: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines (Procedure)
结局指标
主要结局
Assessment of Neurocognitive Function
时间窗: 12 months
To assess post-operative neurocognitive function using the Montreal Cognitive Assessment
次要结局
- Progression-free survival in years(12 months)
- Assessing Quality of Life(12 months)
