Actively Recruiting

Age: 18Years +
All Genders
NCT03222895

Distribution of Lymph Node Metastases in Esophageal Carcinoma

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-02-13

5000

Participants Needed

19

Research Sites

482 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Lymph node status is an important prognostic parameter in esophageal carcinoma and an independent predictor of survival. Distribution of metastatic lymph nodes may vary with tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy differs worldwide. Especially for adenocarcinoma the distribution of lymph node metastases has not yet been described in large series. Aim of the present study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least a 2-field lymphadenectomy. Methods: The TIGER-study is a multinational observational cohort study. All patients with a resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in participating centers will be included. All lymph node stations will be excised and separately sent for pathological examination. Cluster analysis will be performed to identify patterns of metastases in relation to tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Conclusion: TIGER will provide a roadmap of the location of lymph node metastases in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored treatment can be developed on the basis of these results, such as the the optimal radiation field and extent of lymphadenectomy based on the primary tumor characteristics.

CONDITIONS

Official Title

Distribution of Lymph Node Metastases in Esophageal Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction
  • Surgically resectable cancer (cT1-4a, N0-3, M0)
  • Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
  • Planned transthoracic esophagectomy
Not Eligible

You will not qualify if you...

  • Previous thoracic or upper abdominal surgery that disturbs lymph drainage of the esophagus and stomach
  • Presence of in situ carcinoma or high grade dysplasia only

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

2

Instituto Nacional de Câncer

Rio de Janeiro, Brazil

Actively Recruiting

3

University of Toronto

Toronto, Canada

Actively Recruiting

4

Fudan University Shanghai Cancer Center

Shanghai, Yangpu, China, 200032

Actively Recruiting

5

Hospital District of Helsinki and Uusimaa

Helsinki, Finland, 000260

Actively Recruiting

6

University Medical Center of the Johannes Gutenberg University

Mainz, Germany, 55131

Actively Recruiting

7

University of Athens, School of Medicine

Athens, Greece, 11527

Actively Recruiting

8

University of Hong Kong

Hong Kong, Hong Kong, 102

Actively Recruiting

9

Tata Memorial Centre

Mumbai, India

Actively Recruiting

10

IRCCS Policlinico San Donato

Milan, Italy, 20097

Actively Recruiting

11

Ospedale San Raffaele

Milan, Italy

Actively Recruiting

12

University of Verona

Verona, Italy, 37129

Actively Recruiting

13

Uonuma Institute and Niigata University

Niigata, Japan, 9502292

Actively Recruiting

14

Keio University School of Medicine

Tokyo, Japan, 1088345

Actively Recruiting

15

The Cancer Institute Hospital of JFCR

Tokyo, Japan, 1358550

Actively Recruiting

16

Ziekenhuisgroep Twente, Almelo & Hengelo

Almelo, Netherlands

Actively Recruiting

17

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

18

Hospital Universitario del Mar

Barcelona, Spain, 08003

Actively Recruiting

19

Karolinska Institutet

Stockholm, Sweden, 17177

Actively Recruiting

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Research Team

S

Suzanne S Gisbertz, MD, PhD

CONTACT

E

Eliza RC Hagens, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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