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Набор скоро начнётся NCT06552000

Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

Без фазы С лечением NSCLC Non Small Cell Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NovoTTF-200T System.
Кому может быть актуально
Состояния в реестре: NSCLC, Non Small Cell Lung Cancer. Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

Обзор

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.

Подробное описание

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 .

Вмешательства

  • Устройство NovoTTF-200T System
    Exposure/Frequency: 150 kHz Route: Transdermal through patented microarray system to the hemithorax affected with cancer, 2-4 week duration, target 18 hours/day (on average)

Первичные конечные точки

  • Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes. [Срок оценки: approximately 14-28 days]
Вторичные конечные точки (1)
  • Safety of administering TTFields [Срок оценки: approximately 14-28 days]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT06552000 · SCCC 07524; STU-2024-0624

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗