Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment.
The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is "maximum safe resection of the contrast enhancing tumor", but this may in selected cases be extended to simply "maximum safe resection" tailored to the patient and extent of disease at hand.
Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole.
Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma.
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)
盲法说明
Participants will be masked until postoperative period. Outcome assessor will be masked until all predefined outcomes have been analysed
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
- •A suspected diagnosis of supratentorial glioblastoma by MRI.(A)
- •Indication for surgical treatment and where supramarginal resection is considered possible according to the preoperative imaging. This consideration needs to be verified by two specialists in neurosurgery.
- •Negative work-up for other primary tumor(B)
- •Karnofsky performance status of 70 -
- •A) If randomized to supramarginal surgery, intraoperative frozen section must conclude with "high-grade glioma" to be able to proceed. Surgery in two sessions is also possible in supramarginal group if there is no intraoperative frozen section available or frozen section indicate another diagnosis, but final histopathology reveals a glioblastoma. In case of surgery in two session, there must be no more than 30 days between procedures. See flow-chart in attachment
- •B) No suspected primary tumor seen on CT chest, abdomen and pelvis. If relevant symptoms/clinical suspicion also supplement with mammography, dermatologist exam, relevant endoscopies etc.
排除标准
- •Not willing to be randomized.
- •Informed consent not possible (e.g. language barriers, aphasia, cognitive severely impaired).
- •Contrast enhancement volume bilateral OR involving corpus callosum.
- •Contrast enhancement along the ependymal lining of ventricles (contact is however not an exclusion criteria).
- •Contrast enhancement involving several lobes.
- •History of major psychiatric disorder such as psychosis, schizophrenia and/or mood disorder (e.g. depression and bipolar disorder) in need of hospitalization
- •Unfit for participation for any other reason judged by the including physician
研究组 & 干预措施
Conventional surgery
Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.
干预措施: Conventional surgery (Procedure)
Supramarginal surgery
Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe
干预措施: Supramarginal resection (Procedure)
结局指标
主要结局
Overall survival
时间窗: 36 months after the last included patient.
Overall survival according to intention-to-treat
次要结局
- Neurological function(Early postoperative (i.e. prior to radiotherapy) to 36 months)
- Health-related quality of life assessed by EQ-5D 3L(Early postoperative (i.e. prior to radiotherapy) to 36 months)
- Proportion alive(36 months after randomization.)
- Health-related quality of life assessed by BN20(Early postoperative (i.e. prior to radiotherapy) to 36 months)
- Health-related quality of life assessed by EORTC QLQ C30(Early postoperative (i.e. prior to radiotherapy) to 36 months)
- Neurocognition(Early postoperative (i.e. prior to radiotherapy) to 36 months)
- Surgical complication(30 days)
- Margin of resection(Within 72 hours postoperative)
- Proportion with contrast remnant(Within 72 hours postoperative)
- Extent of resection, T2/FLAIR remnant(Within 72 hours postoperative)
- Proportion alive(24 months after randomization.)