Suspended

ECLNI-MCCan Extracapsular Lymph Node Involvement be a Tool to Fine-tune UICC TNM 7th Edition for Esophageal Carcinoma?

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Carcinoma+4

+ Neoplasms by Histologic Type

+ Neoplasms, Glandular and Epithelial

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity Hospital, Gasthuisberg
Last updated: April 23, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The classification of carcinoma of the esophagus has undergone a major modification between the UICC sixth (TNM-6) and TNM-7 edition. Regional lymph nodes (N) are now subdivided by the number of involved lymph nodes (pN0, 0; pN1, 1-2; pN2, 3-6; pN3 > 6), and distant metastasis (M) has been simplified to M1 rather than subdivided by location [1]. Nevertheless, TNM-7 doesn't take into consideration the morphologic characteristics of the metastatic lymph node itself. Since our first publications showing a negative relationship between presence of extracapsular lymph node involvement (EC-LNI) and survival [2], little has been published about the prognostic impact of this specific characteristic . In our latest publication "Can extracapsular lymph node involvement be a tool to fine-tune pN1 for adenocarcinoma in UICC TNM 7th Edition?" [3], the investigators found a significant survival benefit for adenocarcinoma without extracapsular lymph node involvement in pN1 (= 1-2 positive lymph nodes) as compared to N2-N3 disease, treated by primary surgery. Moreover, pN1 patients with extracapsular lymph node involvement (EC-LNI) showed a survival that was comparable to patients with more than 2 positive lymph nodes (i.e. stage IIIB). These findings may have important consequences for future TNM adaptations. The aim of this study is to validate our results on a larger, multicentric cohort, and if possible make recommendations and possible fine-tuning for a future TNM adaptation, including the characteristics of the metastatic lymph node itself, being intra- or extracapsular. Furthermore the investigators want to examine if these effects are valid in pre-treated patients, i.e. surgery after neoadjuvant chemo(radiation) therapy. Although these patients are not incorporated in the current TNM classification, future adaptations to the TNM classification system will also examine the effects of neoadjuvant therapy (cfr. Rice/Blackstone WECC -Worldwide Esophageal Cancer Collaboration).

Principal SponsorUniversity Hospital, Gasthuisberg
Last updated: April 23, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Squamous CellAdenocarcinomaCarcinoma, Squamous CellNeoplasms

Criteria

1 inclusion criteria required to participate
Adequate lymph node sampling is of paramount importance. (pT1 - min. 10 LN; > pT2 min. 20 LN resected). At least the following lymph node stations should be examined: perioesophageal distal 1/3 and perigastric LN, left gastric artery, splenic artery, common hepatic artery, subcarinal lymph nodes. Sugical technique (transthoracic, transhiatal or minimal invasive) is less important if the criterium of adequate lymph node sampling is fulfilled but should be mentioned

4 exclusion criteria prevent from participating
Postoperative (inhospital or 30-day) mortality

histology other than adenocarcinoma or squamous cell carcinoma

subcardia tumors

unforeseen organ metastasis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital Leuven, Gasthuisberg

Leuven, BelgiumOpen University Hospital Leuven, Gasthuisberg in Google Maps
SuspendedOne Study Center