Distribution of Lymph Node Metastases in Esophageal Carcinoma

Status: Recruiting
Location: See all (19) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction

• Surgically resectable (cT1-4a, N0-3, M0)

• Adequate physical condition to undergo transthoracic surgery (ASA 1-3)

• Transthoracic esophagectomy

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Brazil
Instituto Nacional de Câncer
RECRUITING
Rio De Janeiro
Canada
University of Toronto
RECRUITING
Toronto
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Finland
Hospital District of Helsinki and Uusimaa
RECRUITING
Helsinki
Germany
University Medical Center of the Johannes Gutenberg University
RECRUITING
Mainz
Greece
University of Athens, School of Medicine
RECRUITING
Athens
Hong Kong Special Administrative Region
University of Hong Kong
RECRUITING
Hong Kong
India
Tata Memorial Centre
RECRUITING
Mumbai
Italy
IRCCS Policlinico San Donato
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
University of Verona
RECRUITING
Verona
Japan
Uonuma Institute and Niigata University
RECRUITING
Niigata
Keio University School of Medicine
RECRUITING
Tokyo
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Netherlands
Ziekenhuisgroep Twente, Almelo & Hengelo
RECRUITING
Almelo
Amsterdam UMC
RECRUITING
Amsterdam
Spain
Hospital Universitario del Mar
RECRUITING
Barcelona
Sweden
Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Suzanne S Gisbertz, MD, PhD
s.s.gisbertz@amc.nl
+31205669111
Backup
Eliza RC Hagens, BSc
e.r.hagens@amc.uva.nl
+31205669111
Time Frame
Start Date: 2019-03-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 5000
Treatments
TIGER study cohort
This is the entire patient cohort. Alle patients with resectable esophageal cancer undergoing a transthoracic esophagectomy with at least a 2-field lymphadenectomy
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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