Retrospective Review of Esophageal Cancer at MSKCC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy
Pathologic staged T3 tumors (pT3)
Disqualifiers
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
Trial population
Participants undergoing esophagectomy for histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) during the period from 2000 to 2019.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Esophagectomy
Procedure/SurgeryEsophagectomy
Treatment groups
4,000 Participants
are divided into 3 treatment groupsGroup A: Circumferential resection margin (CRM)1 intervention
Group B: Circumferential resection margin (CRM)-close1 intervention
Group C: Circumferential resection margin (CRM)+1 intervention
Trial outcomes
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.
Time frame
Up to 2 yearsSecondary outcomes
1
Overall survival and progression-free survival (measured from date of surgery)
Postoperative outcomes stratified by the type of esophageal cancer surgery performed.
Time frame
Up to 2 years2
Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate).
Time frame
Up to 2 years3
Survival outcomes stratified by treatment modality (i.e., definitive chemoradiation therapy or trimodality treatment).
Time frame
Up to 2 years4
Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy).
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov