NCT05706558

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Dec 2016Feb 2027

Study Start

First participant enrolled

December 13, 2016

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

10.1 years

First QC Date

January 23, 2023

Last Update Submit

March 6, 2026

Conditions

Esophageal CancerEsophagus Cancer

Keywords

Esophageal CancerEsophagus CancerMemorial Sloan Kettering Cancer Center16-1631

Outcome Measures

Primary Outcomes (1)

  • . 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 Outcomes (4)

  • Overall survival and progression-free survival (measured from date of surgery)

    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

Study Arms (3)

Circumferential resection margin (CRM)

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

Procedure: 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

Circumferential resection margin (CRM)+

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

Procedure: Esophagectomy

Interventions

EsophagectomyPROCEDURE

Esophagectomy

Circumferential resection margin (CRM)Circumferential resection margin (CRM)+Circumferential resection margin (CRM)-close

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Daniela Molena, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Molena, MD

CONTACT

212-639-3870molenad@mskcc.org

James Isbell, MD

CONTACT

212-639-6247isbellj@mskcc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

January 31, 2023

Study Start

December 13, 2016

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)