Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Официальное название

A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Обзор

Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group

Подробное описание

Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.

Вмешательства

• Препарат chemotherapy
  patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles

Первичные конечные точки

• Disease-free survival [Срок оценки: At most 5 years after enrollment]

Вторичные конечные точки (1)

• overall survival [Срок оценки: At most 5 years after enrollment]

Критерии участия

Критерии включения

• Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
• T≥3 or N≥1, and more than 15 lymph nodes were dissected.
• Age ≥18 years and ≤75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Adequate hematological function:

absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.

• Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
• Adequate renal function:

serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.

• Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent

Критерии исключения

• Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
• Serious postoperative complications that will affect progress of chemotherapy.
• Patients with chemotherapy contraindications.
• Women who are pregnant or breast-feeding or who are planning for pregnancy.
• Unable to complete the follow-up as planned.
• Without informed consent due to psychological, family, social and other factors.

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 · 1 центр

• Sun Yat-sen Uniersity Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT04174079 · B2019-061-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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