Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

Официальное название

Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial

Обзор

Esophageal squamous cell carcinoma (ESCC) is one of the most aggressive malignant tumors. Although neoadjuvant chemoradiotherapy combined with surgery has significantly improved the survival rate of patients with locally advanced esophageal cancer, approximately half of the patients will experience local regional recurrence or distant metastasis. Lymphocytes are crucial immune cells in the human body, playing a key role in combating infections and tumor development. In recent years, an increasing body of research has indicated that lymphocyte depletion is a significant factor associated with poor prognosis in various solid tumors, including esophageal cancer. The lymphocyte depletion caused by radiotherapy has garnered considerable attention from oncologists. However, there is still a lack of prospective clinical research data on lymphocyte protection in thoracic tumors. Therefore, this study aims to provide high-level evidence from evidence-based medicine regarding the correlation between lymphocyte depletion and prognosis in esophageal cancer patients, offering more effective strategies and methods to improve the outcomes of neoadjuvant chemoradiotherapy for esophageal cancer.

Вмешательства

• Лучевая терапия lymphocyte-sparing radiotherapy
  the radiotherapy regimen is 41.4Gy/23Fx. Ensure 95% coverage of the PTV (Planning Target Volume) and limit the doses to the heart, bilateral lungs, and spinal cord to meet the required dose constraints. While maintaining target coverage and traditional OAR (Organs At Risk) dose constraints, also address dose for lymphocyte-relate organs including the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels.
• Лучевая терапия conventional radiotherapy
  the radiotherapy regimen is 41.4Gy/23Fx. Ensure 95% coverage of the PTV (Planning Target Volume) and limit the doses to the heart, bilateral lungs, and spinal cord to meet the required dose constraints. do not limit dose for lymphocyte-relate organs including the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels.

Первичные конечные точки

• acute grade 3/4 lymphopenia [Срок оценки: 1 months after surgery]

Вторичные конечные точки (7)

• Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group [Срок оценки: within 1 week after completion of neoadjuvat radiotherapy plan;]
• Incidence of grade 3 or higher hematologic toxicity [Срок оценки: from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy]
• Pathological complete response rate (pCR) [Срок оценки: 1 months after surgery]
• R0 resection rate [Срок оценки: 1 month after surgery]
• Postoperative complications [Срок оценки: 1 month after surgery]
• recurrence-free survival [Срок оценки: 2 year]
• Overall survival [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Patients are able to understand and are willing to participate in the trial, and a signed consent form can be obtained;
• Pathologically confirmed esophageal squamous cell carcinoma;
• locally advanced ESCC (cT3-4 or N+);
• the age of patients should be more than 18 years, and less than 80 years;
• aged between 18 and 80 years;
• KPS score of patients should be more than 80

Критерии исключения

• diagnosis of metastatic esophageal cancer;
• Patient refuses to receive systemic drug treatment;
• clinical diagnosis of pleural metastasis or malignant pleural effusion;
• Pregnant or breastfeeding women;
• Severe non-cancerous medical comorbidities that affect the implementation of radiotherapy.

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

Китай · 1 центр

• Ruijin hospital, Shanghai jiaotong university school of medicine — Шанхай

Публикации

• Qi WX, Li S, Li H, Zhang S, Cai G, Xu C, Zhang Y, Chen J, Zhao S. Sparing lymphocytes during preoperative adjuvant radiotherapy for oesophageal squamous cell carcinoma (SPARE): protocol for an open-label, randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e096803. doi: 10.1136/bmjopen-2024-096803. PMID 40976677

Идентификаторы

NCT: NCT06596954 · 2024-210

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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