This trial is active, not recruiting.

Condition esophageal cancer
Sponsor University Hospital, Gasthuisberg
Start date July 2013
End date December 2013
Trial size 923 participants
Trial identifier NCT01959906, CRM<1mm


A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Complete resection
Incomplete resection, microscopical tumor residu left behind
complete resection (R0), however tumor spreads till less than 1 mm from the section pane.

Primary Outcomes

overall survival
time frame: 5 years after esophagectomy

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

Inclusion Criteria: - pathologic T3 tumours of esophagus or GEJ Exclusion Criteria: - pT other than pT3 - R2 resections

Additional Information

Official title Prognostic Value of a Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.
Principal investigator Katrien Van de Steen, MSc
Description From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery. Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University Hospital, Gasthuisberg.