Distribution of Lymph Node Metastases in Esophageal Carcinoma

NCT03222895 | Recruiting

• 1 other identifier: W17_069
• Study Type: observational
• Target: 5,000
• Locations: 14 countries
• Sites: 19

Brief 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.

Conditions

Esophageal Neoplasms; Lymph Node Metastases

Keywords

Esophageal Neoplasms; Lymph node metastases; Esophagectomy

Outcome Measures

Primary Outcomes (1)

• Distribution of lymph node metastases

  The distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival.

  2 years

Secondary Outcomes (7)

• Accuracy of preoperative diagnostics

  2 years

• Prognostic value of different lymph node stations

  2 years

• Distribution pattern of recurrence or metastases

  2 years

• Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy

  2 years

• Skip nodal metastases

  2 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with esophageal cancer who will undergo a transthoracic esophagectomy with a 2- or 3 field lymphadenectomy for esophageal cancer in one of the participating centers during the inclusion period.

You may qualify if:

• 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

You may not qualify if:

• Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
• Patients with in situ carcinoma or high grade dysplasia

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (19)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Instituto Nacional de Câncer

Rio de Janeiro, Brazil

RECRUITING

University of Toronto

Toronto, Canada

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Yangpu, 200032, China

RECRUITING

Hospital District of Helsinki and Uusimaa

Helsinki, 000260, Finland

RECRUITING

University Medical Center of the Johannes Gutenberg University

Mainz, 55131, Germany

RECRUITING

University of Athens, School of Medicine

Athens, 11527, Greece

RECRUITING

University of Hong Kong

Hong Kong, 102, Hong Kong

RECRUITING

Tata Memorial Centre

Mumbai, India

RECRUITING

IRCCS Policlinico San Donato

Milan, 20097, Italy

RECRUITING

Ospedale San Raffaele

Milan, Italy

RECRUITING

University of Verona

Verona, 37129, Italy

RECRUITING

Uonuma Institute and Niigata University

Niigata, 9502292, Japan

RECRUITING

Keio University School of Medicine

Tokyo, 1088345, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 1358550, Japan

RECRUITING

Ziekenhuisgroep Twente, Almelo & Hengelo

Almelo, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Hospital Universitario del Mar

Barcelona, 08003, Spain

RECRUITING

Karolinska Institutet

Stockholm, 17177, Sweden

RECRUITING

Related Publications (1)

• Hagens ERC, van Berge Henegouwen MI, van Sandick JW, Cuesta MA, van der Peet DL, Heisterkamp J, Nieuwenhuijzen GAP, Rosman C, Scheepers JJG, Sosef MN, van Hillegersberg R, Lagarde SM, Nilsson M, Rasanen J, Nafteux P, Pattyn P, Holscher AH, Schroder W, Schneider PM, Mariette C, Castoro C, Bonavina L, Rosati R, de Manzoni G, Mattioli S, Garcia JR, Pera M, Griffin M, Wilkerson P, Chaudry MA, Sgromo B, Tucker O, Cheong E, Moorthy K, Walsh TN, Reynolds J, Tachimori Y, Inoue H, Matsubara H, Kosugi SI, Chen H, Law SYK, Pramesh CS, Puntambekar SP, Murthy S, Linden P, Hofstetter WL, Kuppusamy MK, Shen KR, Darling GE, Sabino FD, Grimminger PP, Meijer SL, Bergman JJGHM, Hulshof MCCM, van Laarhoven HWM, Mearadji B, Bennink RJ, Annema JT, Dijkgraaf MGW, Gisbertz SS. Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study. BMC Cancer. 2019 Jul 4;19(1):662. doi: 10.1186/s12885-019-5761-7.

  PMID: 31272485 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne S Gisbertz, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

• Mark I van Berge Henegouwen, MD, PHD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Eliza RC Hagens, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY DIRECTOR

Central Study Contacts

Suzanne S Gisbertz, MD, PhD

CONTACT

+31205669111; s.s.gisbertz@amc.nl

Eliza RC Hagens, BSc

CONTACT

+31205669111; e.r.hagens@amc.uva.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Upper GI Surgeon

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: March 1, 2019
• Primary Completion: January 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); BR (1); DE (1); ES (1); SE (1); US (1); IT (3); CA (1); CN (1); HK (1); JP (3); FI (1); IN (1); GR (1)