NCT05420480

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Two-Field lymph node dissection	The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with "Two-Field" or "Three-Field" lymph node dissection.
PROCEDURE	Three-Field lymph node dissection	The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with "Two-Field" or "Three-Field" lymph node dissection.
PROCEDURE	Three-Field lymph node dissection	The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-01
• Completion: 2027-06-01
• First posted: 2022-06-15
• Last updated: 2022-06-21

Locations

1 site across 1 country: China