Retrospective Review of Esophageal Cancer at MSKCC

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Esophagus Cancer
• Intervention / Treatment: Procedure: Esophagectomy

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Daniela Molena, MD; Phone Number: 212-639-3870; Email: molenad@mskcc.org
• Study Contact Backup: Name: James Isbell, MD; Phone Number: 212-639-6247; Email: isbellj@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants undergoing esophagectomy for histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) during the period from 2000 to 2019.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Circumferential resection margin (CRM); Participants will have a diagnosis of esophageal carcinoma and residual tumor >1 mm from the CRM	Procedure: Esophagectomy; Esophagectomy
Circumferential resection margin (CRM)-close; Participants will have a diagnosis of esophageal carcinoma and residual tumor >0-1 mm from the CRM	Procedure: Esophagectomy; Esophagectomy
Circumferential resection margin (CRM)+; Participants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM	Procedure: Esophagectomy; Esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)	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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival and progression-free survival (measured from date of surgery)	Postoperative outcomes stratified by the type of esophageal cancer surgery performed.	Up to 2 years
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
Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy).		Up to 2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Daniela Molena, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2016
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Esophageal Cancer; Esophagus Cancer; 16-1631
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Surgical Procedures, Operative; Digestive System Surgical Procedures; Esophagectomy
• Other Study ID Numbers: 16-1631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No