Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.
研究概览
简要总结
The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.
详细描述
To study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA NSCLC.
Participants in this study will have a blood sample collected as well as vital signs along with a tumor tissue sample and tumor scan. Once it has been determined the participant can enroll into this study, he/she will come to the clinic for 5 scheduled visits over a period of 2 months .
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage I-IIIA NSCLC planned for surgical resection.
- •Eastern Cooperative Oncology Group (ECOG) 0-2 performance status.
- •Willingness and ability to undergo planned correlative studies, including imaging tests.
- •Fresh biopsy diagnostic material obtained from standard of care procedure to perform baseline correlatives (10-15 slides)-if not available, enrollment will be considered on a case-by-case basis after discussion with and approval by the Lead Site PI or Lead Site Co-Principal Investigator.
- •Ability to understand and the willingness to sign a written informed consent.
- •All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •• Has not undergone a hysterectomy or bilateral oophorectomy; or
- •• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Age ≥22 years at time of screening.
排除标准
- •Receipt of prior therapy for the current NSCLC.
- •Planned neoadjuvant therapy for the current NSCLC.
- •History of major allergic reactions attributed to adhesive or compounds in TTFields micro-array.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- •Pregnant or nursing patients due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- •Use of electronic devices or prosthetics - i.e., pacemakers, defibrillators, spinal infusion pumps. Specific scenarios can be discussed with the Lead Site PI or Lead Site Co-Principal Investigator.
研究组 & 干预措施
Tumor Treatment Fields
Duration: 2-4 week; target 18 hours/day (on average). Continuous between time of enrollment and date of surgery.
Cycle Length: 2-4 weeks
干预措施: NovoTTF-200T System (Device)
结局指标
主要结局
Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.
时间窗: approximately 14-28 days
Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC.
次要结局
- Safety of administering TTFields(approximately 14-28 days)
研究者
John Waters
Assistant Professor, Cardiovascular & Thoracic Surgery
University of Texas Southwestern Medical Center