What this study is
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.
Study details
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Conditions
- Esophageal Neoplasms · Lymph Node Metastases
- Enrolling
- 5,000 people
- Starts
- 2019-03-01
- Est. completion
- 2028-06-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (19)
19 openMD Anderson Cancer Center
Houston, Texas, United States
- W.L. Hofstetter, MD, PhD · Contact
Recruiting
18 sites outside the US
Instituto Nacional de Câncer
Rio de Janeiro, Brazil
- C.E. Pinto, MD, PhD · Contact
RecruitingUniversity of Toronto
Toronto, Canada
- Gail Darling, MD PhD · Contact
RecruitingFudan University Shanghai Cancer Center
Shanghai, Yangpu, China
- H. Chen, MD, PhD · Contact
RecruitingHospital District of Helsinki and Uusimaa
Helsinki, Finland
- J. Räsänen, MD, PhD · Contact
RecruitingUniversity Medical Center of the Johannes Gutenberg University
Mainz, Germany
- P. Grimminger, MD, PhD · Contact
RecruitingUniversity of Athens, School of Medicine
Athens, Greece
- D. Theodorou, MD, PhD · Contact
RecruitingUniversity of Hong Kong
Hong Kong, Hong Kong
- S.Y.K Law, MD, PhD · Contact
RecruitingTata Memorial Centre
Mumbai, India
- C.S. Pramesh, MD, PhD · Contact
RecruitingIRCCS Policlinico San Donato
Milan, Italy
- L. Bonavina, MD, PhD · Contact
RecruitingOspedale San Raffaele
Milan, Italy
- Riccardo Rosati, MD · Contact
RecruitingUniversity of Verona
Verona, Italy
- G. de Manzoni, MD, PhD · Contact
RecruitingUonuma Institute and Niigata University
Niigata, Japan
- S. Kosugi, MD, PhD · Contact
RecruitingKeio University School of Medicine
Tokyo, Japan
- Y. Kitagawa, MD, PhD · Contact
RecruitingThe Cancer Institute Hospital of JFCR
Tokyo, Japan
- M. Watanabe, MD, PhD · Contact
RecruitingZiekenhuisgroep Twente, Almelo & Hengelo
Almelo, Netherlands
- E. Kouwenhoven, MD, PhD · Contact
RecruitingAmsterdam UMC
Amsterdam, Netherlands
- Suzanne S Gisbertz, MD PhD · Contact
RecruitingHospital Universitario del Mar
Barcelona, Spain
- M. Pera, MD, PhD · Contact
RecruitingKarolinska Institutet
Stockholm, Sweden
- M. Nilsson, MD, PhD · Contact
Recruiting
Study team
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID W17_069
Study chair
Suzanne S Gisbertz, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal investigator
Mark I van Berge Henegouwen, MD, PHD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study director
Eliza RC Hagens, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.