Меню
Идёт набор NCT04328948

A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC

Фаза III С лечением Esophageal Squamous Cell Carcinoma

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: Chemoradiotherapy.
Кому может быть актуально
Состояния в реестре: Esophageal Squamous Cell Carcinoma. Базовые параметры: от 20 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
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer

Обзор

This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.

Вмешательства

  • Лучевая терапия Chemoradiotherapy
    Chemoradiotherapy

Первичные конечные точки

  • Major progression-free survival [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]
Вторичные конечные точки (6)
  • Overall survival [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Progression-free survival [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Complete response rate [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Esophagectomy-free survival [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Adverse events [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Long term toxicity [Срок оценки: The primary analysis will be held 5-years after the last patient was enrolled.]

Критерии участия

Критерии включения

  • Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
  • All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
  • Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
  • The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.
  • Aged 20 years and older.
  • ECOG Performance status 0 or 1.
  • No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration.
  • No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.
  • Major organ function is preserved. 1) WBC<=12,000/mm3 2) ANC>=1,500/mm3 3) Hb>=10.0 g /dL 4) PLT>=10,000/mm3 5) T-bil<=1.5 mg /dL 6) AST<=100 IU/L 7) ALT<=100 IU/L 8) SpO2>=95% 9) Ccr>=60 mL/min
  • Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
  • Written informed consent is obtained.

Критерии исключения

  • Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.
  • Active infection requiring systemic therapy.
  • Fever over 38 degrees Celsius
  • Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.
  • Psychological disorder, which is difficult to participate in this clinical study.
  • Receiving continuous systemic corticosteroid or immunosuppressant treatment.
  • Positive for HBs antigen or HIV antigen.
  • Diabetes mellitus, which is uncontrollable with continuous use of insulin or hypoglycemic agents.
  • Uncontrolled arterial hypertension.
  • History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
  • Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
  • Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
  • With a history of cerebrovascular disorder within 6 months.
  • Drug allergy for iodic drugs.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Япония · 1 центр
  • National Cancer Center Hospital — Tokyo

Идентификаторы

NCT: NCT04328948 · JCOG1904

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗