Supratotal Resection for Gliomas Within Noneloquent Areas: A Single Center Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) rates
研究概览
简要总结
Gliomas, especially high grade gliomas and diffuse low grade gliomas, are characterized by their infiltrative nature. Recently, a new conception of supratotal resection has been proposed. Given the lack of prospective supporting data, the correlation between supratotal resection and the survival of patients with glioma need to be established.
Therefore, the investigators aim to do a single center prospective randomized controlled clinical trial to assess the effect of supratotal resection at least 1 cm beyond the MR imaging-defined abnormalities on progression-free survival (PFS) of glioma.
详细描述
It has been demonstrated that an extensive resection (total or subtotal) significantly increases the overall survival in patients with gliomas. Yet, recent data have shown that conventional MR imaging underestimates the spatial extent of gliomas, since tumor cells were found to invade beyond MR imaging abnormalities. Thus, it is hypothesized that an extended resection with a margin beyond MR imaging-defined abnormalities-a "supratotal" resection-might improve the outcome of gliomas. However, the exact extent of supratotal resection remains unclear. Unnecessary removal of brain tissue that does not contain cancer cells can lead to neurological deficits that affect quality of life, such as impaired cognition, memory, and vision. Recently, studies from human specimens have shown that infiltrating glioma cells spread about 1cm beyond the gross and radiographic margins of the tumor. The investigators thereof propose to perform extended resection at least 1cm beyond the MRI defined margin might improve the outcome of patients with gliomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Individuals aged 18-80 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated glioma
- •Tumor in noneloquent brain areas diagnosed by Head MRI, an eloquent areas is defined according to the recent UCSF (University of California, San Francisco) classification, including the sensor motor areas (precentral and postcentral gyri), perisylvian language areas in the dominant hemisphere (superior temporal, inferior frontal, and inferior parietal gyri), basal ganglia, internal capsule, thalamus, and visual cortex around the calcarine sulcus
- •Lesions located at least 1 cm far away from an eloquent area and important subcortical tracts such as pyramidal tract, uncinate fasciculus (preoperatively roughly estimated by MRI and DTI)
- •Individuals who can accept and complete Stupp regimen therapy after surgery
- •Karnofsky performance scale (KPS) 70 or more
- •All patients giving written informed consent.
排除标准
- •Individuals with age < 18 years or > 80 years
- •Tumors in eloquent areas, as well as tumors with long invasion (i.e., crossing the corpus callosum) and deep seated tumors (i.e., basal ganglia)
- •Recurrent gliomas after surgery (except needle biopsy)
- •Pregnancy or breast-feeding women
- •Unable to achieve imaging data
- •Inability to give written informed consent
- •Heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.
结局指标
主要结局
Progression-free survival (PFS) rates
时间窗: 2 years
次要结局
- Volume of resection(3 days)
- Karnofsky performance scale (KPS)(2 years)
研究者
Rong Hu
Associate Professor, Associate Chief Neurosurgeon
Southwest Hospital, China