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Идёт набор NCT04135664

Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

Фаза III С лечением Esophageal 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: esophagectomy, chemoradiation, active surveillance.
Кому может быть актуально
Состояния в реестре: Esophageal Cancer. Базовые параметры: 18 лет — 75 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
Китай
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

Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial

Обзор

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

Подробное описание

Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.

The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.

The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.

The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.

The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.

Вмешательства

  • Процедура esophagectomy
    esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
  • Комбинированный продукт chemoradiation
    concurrent chemotherapy and radiotherapy
  • Другое active surveillance
    No further adjuvant therapy

Первичные конечные точки

  • 5-year overall survival rate [Срок оценки: 5 years after enrollment day]
Вторичные конечные точки (5)
  • 3-year overall survival rate [Срок оценки: 3 years after enrollment day]
  • 3-year relapse free survival rate [Срок оценки: 3 years after enrollment day]
  • 5-year relapse free survival rate [Срок оценки: 5 years after enrollment day]
  • Quality of life differences (EORTC QLQ-C30) [Срок оценки: 1st, 3rd, 6th, 12th and 24th month after enrollment]
  • Quality of life differences (EORTC QLQ-OES18) [Срок оценки: 1st, 3rd, 6th, 12th and 24th month after enrollment]

Критерии участия

Критерии включения

  • Biopsy proven with esophageal squamous cell cancer.
  • Clinical N0 stage diagnosed by imaging examinations.
  • Pathological T1b stage confirmed by endoscopic submucosal dissection.
  • Age: 18-75.
  • Tumor located at the thorax.
  • Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Written informed consent.

Критерии исключения

  • Prior intervention treatment before endoscopic submucosal resection.
  • Inability to accept any treatment component.
  • Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
  • Distant metastasis.
  • The circumference of the lumen over 3/4
  • Main tumor size > 5cm assessed by endoscopy
  • Inability to understand the informed consent.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 6 центров
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • Changhai Hospital, The Second Military Medical University — Шанхай
  • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine — Шанхай
  • Shanghai Chest Hospital, Shanghai Jiao Tong University — Шанхай
  • Zhongshan Hospital, Fudan University — Шанхай
  • Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Публикации

  • Yang Y, Su Y, Zhang X, Liu J, Zhang H, Li B, Hua R, Tan L, Chen H, Li Z. Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial). Trials. 2020 Jul 1;21(1):603. doi: 10.1186/s13063-020-04461-5. PMID 32611448

Идентификаторы

NCT: NCT04135664 · Chest201908

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗