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Clinical Trials/NCT05706558
NCT05706558RecruitingNot Applicable

Retrospective Review of Esophageal Cancer at MSKCC

Memorial Sloan Kettering Cancer Center1 site in 1 country4,000 target enrollmentStarted: December 13, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
4,000
Locations
1
Primary Endpoint
. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Circumferential resection margin (CRM)

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

Intervention: Esophagectomy (Procedure)

Circumferential resection margin (CRM)-close

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

Intervention: Esophagectomy (Procedure)

Circumferential resection margin (CRM)+

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

Intervention: Esophagectomy (Procedure)

Outcomes

Primary Outcomes

. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)

Time Frame: 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 Outcomes

  • 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 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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