Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05706558

Conditions

Esophageal Cancer

Esophagus Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Esophagectomy

Study Details

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.

Conditions

Esophageal Cancer

Esophagus Cancer

Study ID

NCT05706558

Start date

Dec 13, 2016

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Circumferential resection margin (CRM)

Participants will have a diagnosis of esophageal carcinoma and residual tumor >1 mm from the CRM

Circumferential resection margin (CRM)-close

Participants will have a diagnosis of esophageal carcinoma and residual tumor >0-1 mm from the CRM

Circumferential resection margin (CRM)+

Participants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM

Interventions

Esophagectomy

Esophagectomy

Primary outcome measure

  • . Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Daniela Molena, MD

212-639-3870molenad@mskcc.org

James Isbell, MD

212-639-6247isbellj@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Daniela Molena, MD

212-639-3870

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Esophageal Cancer
  • Esophagus Cancer
  • Memorial Sloan Kettering Cancer Center
  • 16-1631

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-09.