RecruitingNot ApplicableNCT06596954

Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

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


Sponsor

Ruijin Hospital

Enrollment

212 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified radiotherapy approach for esophageal squamous cell cancer that aims to protect immune cells (lymphocytes) during treatment, with the goal of preserving the body's immune response and potentially improving treatment effectiveness. **You may be eligible if...** - You have been confirmed with esophageal squamous cell carcinoma - Your cancer is locally advanced (involving deeper tissues or nearby lymph nodes) - You are between 18 and 80 years old - You have a Karnofsky performance score above 80 (able to carry out normal activity) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You refuse systemic drug treatment - You have cancer in the lining around the lungs (pleural metastasis) - You are pregnant or breastfeeding - You have severe other medical conditions that make radiotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONlymphocyte-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.

RADIATIONconventional 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.


Locations(1)

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, China, China

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NCT06596954


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