Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months
研究概览
简要总结
This phase II single-arm pilot study will evaluate the safety and preliminary efficacy of Optune-Tumor Treating Fields (TTFields) therapy as a prophylactic approach to reducing small cell lung cancer (SCLC) that has spread to the brain (brain metastases). Optune is a portable battery powered device that produces alternating electrical fields, termed tumor treatment fields ("TTFields") within the human body. These TTFields are applied to the patient by electrically insulated surface transducer arrays, which function to disrupt the rapid cell division of cancer cells.
详细描述
PRIMARY OBJECTIVE:
I. Observed rate of brain metastases following TTFields therapy at 6 months.
SECONDARY OBJECTIVES:
I. Observed rate of brain metastases following TTFields therapy at 12 months. II. Survival of participants with SCLC after using TTFields therapy. III. Usage and overall safety characteristics of TTFields therapy. IV. Quality of life among participants using TTFields therapy. V. Observed rate of SCLC brain metastases at 6 months from the beginning of the 4th cycle of chemotherapy to development of brain metastases.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document
- •Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC
- •LS-SCLC - stage I-III (Tany, Nany, M0) that can be safely treated with radiation doses. Excludes T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
- •ES-SCLC - stage IV (Tany, Nany, M1), or T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
- •Must be no more than 6 weeks from having received last dose of chemo- and/or radiotherapy for primary tumor to anticipated start of TTField therapy
- •Partial response to standard of care (chemo- and/or radiotherapy) as judged by treating physicians with no evidence of recurrence as observed by thoracoabdominal computed tomography (CT) within 12 weeks of enrollment
- •No brain metastases as observed by gadolinium (gd)-magnetic resonance imaging (MRI) within 12 weeks of enrollment
- •No previous or currently active second malignancy, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
- •Life expectancy of at >= 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60)
- •Participants must be willing and able to fully comply with the minimum required 18 hours/day of TTField therapy
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
排除标准
- •Malignant disease, other than that being treated in this study, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
- •Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
- •Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)
- •External medical devices (e.g., insulin pumps) are permitted
- •Skull defect (e.g. missing bone with no replacement)
- •Bullet fragments
- •Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- •Sensitivity to conductive hydrogels
- •Pregnant or lactating women
- •Underlying serious skin condition on the scalp, which in the opinion of the investigator, would prevent or interfere with TTField therapy
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
结局指标
主要结局
Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months
时间窗: 6 months following start of tumor treating fields (TTFields) therapy
次要结局
- Overall Survival(Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months))
- Incidence of SCLC Brain Metastases at 12 Months(12 months following start of TTFields therapy)
- Incidence of TTfield Related Adverse Events(Continuously following start of TTFields therapy (up to 12 months))
- Incidence of Cognitive Adverse Events (AEs) Using Mini Mental State Exam (MMSE)(Continuously following start of TTFields therapy (up to 12 months))
- Change in Quality of Life Over Time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)(6 and 12 months following start of TTFields therapy)
- Incidence of SCLC Brain Metastases(Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days))
研究者
Timur Mitin
Principal Investigator
OHSU Knight Cancer Institute