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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagectomy | Procedure | Esophagectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| . 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate). |
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Inclusion Criteria:
Exclusion Criteria:
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Participants undergoing esophagectomy for histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) during the period from 2000 to 2019.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Molena, MD | Contact | 212-639-3870 | molenad@mskcc.org | |
| James Isbell, MD | Contact | 212-639-6247 | isbellj@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Molena, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |