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Two-field Versus Three-field Lymph Node Dissection in ESCC After Neoadjuvant Therapy

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
Two-field Versus Three-field Lymph Node Dissection for Esophageal Squamous Cell Carcinoma Patients Without Cervical Lymph Node Metastasis After Neoadjuvant Therapy: A Multi-center, Prospective Randomized Controlled Study

Clinical Trial Summary

Comparison of esophagectomy with Two-field Versus Three-field lymphadenectomy in locally advanced ESCC patients after neoadjuvant therapy

Clinical Trial Description

In locally advanced esophageal squamous cell carcinoma patients, neoadjuvant therapy has become a standard therapeutic strategy and been widely administered. Neoadjuvant therapy drastically reduces the metastatic lymph nodes rate as verified in numerous studies including CROSS (Netherlands), JCOG9907/1109 (Japan), NEOCRTEC5010 and CMISG1701 (China) trials, which entails a study to characterize the distribution of lymph node metastasis, and to identify the optimal extent of lymphadenectomy in ESCC patients who received neoadjuvant therapy. This study aims to clarify whether three-field (cervical-thoracic-abdominal) lymphadenectomy will improve survival over two-field (thoracic-abdominal) lymphadenectomy for ESCC patients after neoadjuvant therapy. An estimated 323 patients will be enrolled. Eligible patients will undergo right recurrent laryngeal nerve lymph node dissection (106recR), which will be subjected to intra-operative frozen resection pathological evaluation. If 106recR lymph node reports POSITIVE, patients will undergo esophagectomy with Three-Field lymphadenectomy (n=75). If 106recR lymph node reports NEGATIVE, patients will be randomized at 1:1 ratio into two groups: A) Esophagectomy with Two-Field lymphadenectomy (n=124) or B) Esophagectomy with Three-Field lymphadenectomy (n=124). Analyses will be done according to the intention-to-treat principle. The primary end point is overall survival (OS), calculated from the date of randomization to the date of death from any cause. Secondary end point is Disease-free survival. Other exploratory end points include tumor recurrence pattern, quality of life, peri-operative complications, and the correlation between metastases of 106recR and cervical lymph nodes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05420480
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact Jun Yin
Phone +8613917483128?
Email yin.jun2@zs-hospital.sh.cn
Status Not yet recruiting
Phase N/A
Start date July 1, 2022
Completion date June 1, 2027
View Details
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