Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Cancer
• Interventions: Radiation: lymphocyte-sparing radiotherapy; Radiation: conventional radiotherapy

• Registration Number: NCT06596954
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• 1. Voluntarily participate and provide written informed consent; 2. Pathologically confirmed esophageal squamous cell carcinoma; 3. Age ≥ 18 years and ≤ 80 years; 4. agree to receive neoadjuvant treatment and definitive surgery; 5. KPS≥80

Exclusion Criteria

• 1. Metastatic esophageal cancer; 2. Patient refuses systemic drug treatment; 3. Pleural metastasis or malignant pleural effusion; 4. Pregnant or breastfeeding women; 5. Severe non-cancerous medical comorbidities that affect the implementation of radiotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lymphocyte-sparing radiotherapy	lymphocyte-sparing radiotherapy	Firstly, ensure coverage of the PTV (Planning Target Volume). Secondly, 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 limits for the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels to protect the lymphocyte
conventional radiotherapy	conventional radiotherapy	ensure 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 limits the dose for lymphocyte-related organs

Primary Outcome Measures

Name	Time	Method
acute grade 3/4 lymphopenia	1 months after surgery	from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
Overall survival	3 years	from treatment to death

Secondary Outcome Measures

Name	Time	Method
recurrence-free survival	2 year	from completion of surgery to any recurrence
rate of pathological complete response	1 months after surgery	compare the rate of pathological complete response between lymphocyte-sparing radiotherapy versus conventional radiotherapy

Trial Locations

Locations (1)

Ruijin hospital, Shanghai jiaotong university school of medicine; 🇨🇳 Shanghai, China