SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- NovoTTF-200A device discontinuation rate due to skin toxicity
研究概览
简要总结
This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety and toxicity of combination chemoradiotherapy with NovoTTF-200A device (Optune) treatment in newly diagnosed glioblastoma.
SECONDARY OBJECTIVES:
I. To determine the median progression-free survival of patients with newly diagnosed glioblastoma treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.
II. To evaluate the median overall survival, 1-year overall survival, and event-free survival.
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
- •Patients with pathology confirmed newly diagnosed World Health Organization (WHO) grade IV glioma
- •Karnofsky performance status (KPS) ≥ 60
- •Patients must have recovered from the effects of surgery per treating physician's judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment
- •Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3
- •Platelets ≥ 100,000 cells/mm^3
- •Hemoglobin ≥ 9.0 g/dl
- •Creatinine clearance > 30 mL/min
- •Bilirubin < 2.0 mg/dL
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal range
- •Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose of temozolomide
- •Is able to have magnetic resonance imaging (MRI) with contrast of the brain
- •All subjects must be able to comprehend and sign a written informed consent document. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the written informed consent document.
排除标准
- •Infratentorial disease (defined as glioblastoma [GBM] derived from cerebellum or brainstem)
- •Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
- •A skull defect (such as, missing bone with no replacement)
- •Women of childbearing potential who are pregnant or breastfeeding
- •Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema)
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator
- •Prior radiation treatment to the brain
- •Prior treatment with temozolomide
- •Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
- •Known active collagen vascular disease
研究组 & 干预措施
Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Temozolomide (Drug)
Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Radiation Therapy (Radiation)
Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: NovoTTF-200A Device (Device)
Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Tumor Treating Fields Therapy (Procedure)
结局指标
主要结局
NovoTTF-200A device discontinuation rate due to skin toxicity
时间窗: Up to 30 days after finishing chemoradiation treatment
Discontinuation events are defined as the discontinuation of NovoTTF-200A device for \> 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
次要结局
- Progression-free survival(From enrollment up to 1 year)
- Overall survival(From enrollment up to 1 year)
- Event-free survival(From enrollment up to 1 year)