NCT01959906

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
923

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

October 8, 2013

Last Update Submit

October 9, 2013

Conditions

Esophageal Cancer

Keywords

Esophagectomy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    5 years overall survival after esophagectomy

    5 years after esophagectomy

Study Arms (3)

R0

Complete resection

R1

Incomplete resection, microscopical tumor residu left behind

CRM<1mm

complete resection (R0), however tumor spreads till less than 1 mm from the section pane.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

923 consecutive pT3 patients operated between january 1990 and june 2013

You may qualify if:

  • pathologic T3 tumours of esophagus or GEJ

You may not qualify if:

  • pT other than pT3
  • R2 resections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Philippe Nafteux, MD

    University Hospital Leuven, dept. Thoracic Surgery

    STUDY DIRECTOR

  • Katrien Van de Steen, MSc

    Katholic University Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Datameanager Thoracic Surgery

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

BE(1)