Actively Recruiting

Age: 18Years +
All Genders
ID03222895

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

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the distribution of lymph node metastases in patients with esophageal or gastro-esophageal junction carcinoma who undergo transthoracic esophagectomy with at least a two-field lymphadenectomy. This multinational observational study aims to better understand how lymph node spread varies by tumor location, histology, invasion depth, and use of neoadjuvant therapy. By studying these patterns in a large patient group, the research seeks to inform more tailored treatments, such as optimal radiation fields and surgical approaches. This study includes all patients with resectable esophageal carcinoma undergoing transthoracic esophagectomy with two- or three-field lymphadenectomy in participating centers across 18 countries. All lymph node stations removed during surgery are examined separately. The study will analyze patterns of metastases in relation to tumor characteristics and treatment history, including the use of neoadjuvant chemoradiotherapy. No additional procedures are performed beyond standard care. Participants will be followed for five years after surgery according to national guidelines, with regular follow-up visits scheduled every three months in the first year, every six months during years two to four, and annually in the fifth year. Researchers will collect data on lymph node involvement, recurrence patterns, survival outcomes, and diagnostic accuracy. This information will help identify subgroups of patients with different metastasis patterns and assess long-term disease-free and overall survival.

CONDITIONS

Brief 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 tumor (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 affecting lymph drainage of the esophagus and stomach
  • Patients with in situ carcinoma or high grade dysplasia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration as per routine care

Participants undergo transthoracic esophagectomy with at least 2-field lymphadenectomy according to national guidelines.

Hospital stay with standard post-operative assessments

Long-term Monitoring

Duration - 5 years

Participants are followed up for 5 years after surgery to monitor recurrence, survival, and other outcomes according to national guidelines.

Follow-up visits every 3 months for the first year, every 6 months from year 2 to 4, then annually in year 5

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

E

Eliza RC Hagens, BSc

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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Published Research Related To This Trial

Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.

Eliza R C Hagens, Mark I van Berge Henegouwen, Johanna W van Sandick...

https://pubmed.ncbi.nlm.nih.gov/31272485