A Pilot and Feasibility Trial to Determine the Rate of the Brain Relapse in Small Cell Lung Cancer (SCLC) Patients With Brain Metastases Treated With Stereotactic Radiosurgery (SRS) Followed by Tumor Treating Fields (TTF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of Distant Metastases
研究概览
简要总结
This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).
详细描述
Tumor Treating Fields (TTFields) are low intensity alternating electric fields, which are tuned to interfere with the division process of cancer cells. TTFields are delivered to the region of cancer using an investigational device, called the NovoTTF-200A system. The device is portable, light weighted, battery operated device designed to deliver TTFields to brain metastases from small cell lung cancer (SCLC).
TTFields are a novel, non-invasive regional anti-mitotic treatment modality. Pre-clinical studies and clinical data in glioblastoma multiforme (GBM) have demonstrated a favorable safety profile and clinical superiority when treating the brain with TTFields. In addition, durable response have been demonstrated with 200kHz TTFields monotherapy for supratentorial tumors of the brain.
The development of brain metastases is devastating for SCLC patients and their families. Treatment options in this setting are limited to SRS or WBRT or a combination thereof. Few clinicians treat SCLC brain metastases with SRS alone because intracranial recurrence is high due to the fact that the entire brain is not treated. WBRT treats the entire brain and improves intracranial control, but at the risk of neurocognitive complications. Thus, new therapeutic options are needed, particularly ones that allow for greater intracranial control while minimizing the risk of neurocognitive adverse events. As such, TTFields following SRS may allow for sufficient regional treatment of the brain to eliminate any remaining tumor cells following radiosurgery as well as micro-metastases that remain untreated, and ultimately prolong intracranial control. Due to the favorable safety profile seen in phase III recurrent and newly diagnosed glioblastoma trials and in which the patients reported improved neurocognitive and emotional functioning, NovoTTF-200A is not expected to have neuro-toxic effects seen with WBRT.
Thus, the investigators hypothesize that the use of NovoTTF-200A applied to the brain following SRS for SCLC brain metastases will have cerebral control comparable to WBRT with less neurocognitive effects.
The patient will undergo stereotactic radiosurgery (SRS). Radiosurgery is a single treatment and will be done as an outpatient procedure.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must have history of histologically confirmed small cell lung cancer. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
- •Brain metastases that have not received radiotherapy previously (metastases on post-contrast MRI obtained within six weeks of study entry) deemed to be amenable to SRS.
- •Longest diameter < 4 cm
- •Prior prophylactic cranial irradiation (PCI) is allowed. The maximum allowed dose is 25Gy in 10 fractions.
- •Prior systemic therapy is allowed after diagnosis of brain metastases provided that restaging MRI shows measurable intracranial disease.
- •Karnofsky Performance Status (KPS) of greater than or equal to
- •Age greater than or equal to 18 years.
- •Life expectancy greater than 3 months.
- •Must receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administration.
- •Ability to operate the NovoTTF-200A device independently or with caregiver aid.
- •Previous clinical trial enrollment is allowed.
- •Subjects given written informed consent.
排除标准
- •History of prior brain metastases.
- •Patients with significant edema leading to risk of brain herniation.
- •History of prior whole brain radiotherapy (WBRT) other than prophylactic cranial radiation. Prophylactic cranial radiation with a maximum dose of 25 Gy delivered as 10 fractions is allowed. WBRT in excess of 25 Gy (anything over 25 Gy) is not allowed.
- •Diffuse Leptomeningeal metastases with radiographic involvement in the brain and/or spinal cord. This does not include local leptomeningeal involvement which is defined as leptomeningeal enhancement within direct contact of targetable metastases.
- •Implantable electronic device in the brain.
- •Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- •Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness).
- •Known allergies to medical adhesives or hydrogel.
- •Currently pregnant or breastfeeding.
- •Concurrent brain-directed therapy.
- •Insufficient recovery from all active toxicities of prior therapies.
- •Women of childbearing potential who are not using an effective method of contraception are excluded.
结局指标
主要结局
Rate of Distant Metastases
时间窗: From date of first SRS treatment to time of the 6 month follow-up MRI
Rate of distant CNS metastases/progression will be calculated as the total number of patients with such events divided by the total number of patients.
次要结局
- Local Recurrence(From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.)
- Distant CNS Progression(From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.)
- Overall Survival(From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.)
研究者
Drexell Hunter Boggs
Principal Investigator
University of Alabama at Birmingham