NCT02893137已完成1 期
Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Frequency of serious adverse events
研究概览
简要总结
The present study proposes a new and potentially superior clinical approach to Optune™ therapy of selected glioblastoma patients. The approach is based on combining TTFields with targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr holes, designed for the individual patient. Pre-clinical modeling results suggest that such procedures may enhance the induced electrical field strength by up to ~100% and thereby potentially improve the clinical outcome of treated patients to a significant extent.
The study is an open label phase 1 clinical pilot experiment designed to investigate feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of glioblastoma will be included in the trial. All patients will receive TTFields therapy with targeted craniotomy and best physician's choice chemotherapy.
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
- •Pathological evidence of GBM using WHO classification criteria
- •Estimated survival minimum three months
- •Supratentorial tumor
- •Not a candidate for further radiotherapy
- •First disease recurrence in accordance with RANO criteria
- •Karnofsky scale score minimum 70
- •Ability to comply with Optune therapy
- •Tumor characteristics which indicate significant expected benefit from feasible craniotomy or skull remodelling surgery combined with TTFields
- •Focal tumor
- •Most superficial border of tumor or resection cavity closer than 2 cm from brain surface
- •Use of validated anti-conception for female participants in accordance with guidelines provided by the Danish Health and Medicines Authority
- •Signed written consent form
排除标准
- •Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy
- •Less than four weeks since radiation therapy
- •Infratentorial tumor
- •Implanted pacemaker, programmable shunt, defibrillator, deep brain stimulator, other implanted devices in the brain, or documented clinically significant arrhythmias.
- •Uncontrollable symptomatic epilepsy, refractory to standard medication. Epilepsy will not necessarily contraindicate participation in the trial as this is a common complication to the disease. Eligibility will be determined by the examining physician and investigators in conjunction upon careful consideration of patient safety.
- •Contraindications for skull remodelling surgery, e.g. bleeding diathesis or severe infection.
- •Significant co-morbidities (within four weeks prior to enrolment)
- •Significant liver function impairment - ALT > 3 times the upper limit of normal
- •Total bilirubin > upper limit of normal
- •Significant renal impairment (serum creatinine > 1.7 mg/dL)
- •Coagulopathy (as evidenced by PT or APTT > 1.5 times control in normal individuals not undergoing anticoagulation)
- •Thrombocytopenia (platelet count < 100x10^3/μL )
- •Anemia (Hb < 10 g/L)
- •Active participation in another clinical treatment trial
- •Patients will be regarded as participants when they have signed a consent form and have been found suitable for enrolment by the examining physician, in accordance with the abovecriteria. Patients may receive medication depending on their clinical condition and other diseases.
结局指标
主要结局
Frequency of serious adverse events
时间窗: Through study completion, an average of 18 months.
Based on CTCAE.
次要结局
- % 1-year survival(Through study completion, an average of 18 months.)
- Overall survival(Through study completion, an average of 18 months.)
- Cumulative corticosteroid dosage(Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.)
- Progression free survival(Through study completion, an average of 18 months.)
- Progression free survival at six months(Through study completion, an average of 18 months.)
- Objective response rate(Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.)
- Quality of life(Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.)
- Karnofsky performance score(Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.)
研究者
研究点 (2)
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