Retrospective Review of Esophageal Cancer at MSKCC

Recruiting

• Conditions: Esophagus Cancer; Esophageal Cancer
• Interventions: Procedure: Esophagectomy

• Registration Number: NCT05706558
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, the investigators sought to evaluate the prognostic significance of the CRM in patients with esophageal cancer undergoing resection.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-13
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy
• Pathologic staged T3 tumors (pT3)

Exclusion Criteria

• Pathologic staged T0-2 (pT0-2) or T4 tumors (pT4)
• Patients with histologic types other than EAC or ESCC, dysplasia or carcinoma in situ without tumor invasion,
• Patients undergoing salvage esophagectomy
• Evidence of distant metastatic disease
• Patients with a positive proximal or distal margin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Circumferential resection margin (CRM)-close	Esophagectomy	Participants will have a diagnosis of esophageal carcinoma and residual tumor \>0-1 mm from the CRM
Circumferential resection margin (CRM)+	Esophagectomy	Participants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM
Circumferential resection margin (CRM)	Esophagectomy	Participants will have a diagnosis of esophageal carcinoma and residual tumor \>1 mm from the CRM

Primary Outcome Measures

Name	Time	Method
. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)	Up to 2 years	Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery) and the association between patient characteristics, neoadjuvant therapy, and postoperative morbidity.

Secondary Outcome Measures

Name	Time	Method
Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy).	Up to 2 years
Overall survival and progression-free survival (measured from date of surgery)	Up to 2 years	Postoperative outcomes stratified by the type of esophageal cancer surgery performed.
Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate).	Up to 2 years
Survival outcomes stratified by treatment modality (i.e., definitive chemoradiation therapy or trimodality treatment).	Up to 2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States