Retrospective Review of Esophageal Cancer at MSKCC

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05706558
• Collaborator: (none)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 73.6
• Patients Per Site Per Month: 54.3

Study Details

Study Description

Brief Summary

Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in esophageal cancer participants; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, we sought to evaluate the prognostic significance of the CRM in participants with esophageal cancer undergoing resection.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer; Esophagus Cancer	Procedure: Esophagectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Review of Esophageal Cancer at MSKCC
• Actual Study Start Date: Dec 13, 2016
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Identify preoperative variables that may affect surgical outcomes and to determine the relation between patient's characteristics, neoadjuvant therapy and postoperative morbidity. [Up to 2 years]

Secondary Outcome Measures

1. Compare different surgical techniques and their associated postoperative outcomes. [Up to 2 years]

2. Evaluate the impact of the delay to surgery after neoadjuvant therapy. [Up to 2 years]

3. Compare results between definitive chemoradiation therapy and three modality treatment [Up to 2 years]

4. Assess the impact of adjuvant therapy in esophageal cancer [Up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT05706558
• Other Study ID Numbers: 16-1631
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Esophageal Cancer; Esophagus Cancer; Memorial Sloan Kettering Cancer Center; 16-1631
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Jan 31, 2023