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NCT05706558 Clinical Trial

Retrospective Review of Esophageal Cancer at MSKCC

Esophageal Cancer Clinical Trial

Official title:
Retrospective Review of Esophageal Cancer at MSKCC

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05706558
Other study ID # 16-1631
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2016
Est. completion date February 2025

Study information
Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact Daniela Molena, MD
Phone 212-639-3870
Email molenad@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Esophagectomy
Esophagectomy

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary . 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 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
Secondary Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate). Up to 2 years
Secondary Survival outcomes stratified by treatment modality (i.e., definitive chemoradiation therapy or trimodality treatment). Up to 2 years
Secondary Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy). Up to 2 years
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