Distribution of Lymph Node Metastases in Esophageal Carcinoma (TIGER)
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|ClinicalTrials.gov Identifier: NCT03222895|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2017
Last Update Posted : January 30, 2018
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 with 58 participating centers. 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.
|Condition or disease|
|Esophageal Neoplasms Lymph Node Metastases|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Distribution of Lymph Node Metastases in Esophageal Carcinoma|
|Anticipated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2024|
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
- Distribution of lymph node metastases [ Time Frame: 2 years ]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.
- Accuracy of preoperative diagnostics [ Time Frame: 2 years ]Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS to existing staging with EUS/PET-CT
- Prognostic value of different lymph node stations [ Time Frame: 2 years ]Prognostic value of different lymph node stations
- Distribution pattern of recurrence or metastases [ Time Frame: 2 years ]Distribution pattern of recurrence or metastases, In-field- or out-field nodal recurrence in case of neo-adjuvant chemoradiation
- Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy [ Time Frame: 2 years ]Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy
- Skip nodal metastases [ Time Frame: 2 years ]Analysis of the phenomenon skip nodal metastases
- Ratio of nodal metastases inside and outside the radiation field [ Time Frame: 2 years ]Ratio of nodal metastases inside and outside the radiation field
- 3- and 5-year overall and disease free survival [ Time Frame: 7 years ]3- and 5-year overall and disease free survival in relation to the lymph node distribution pattern
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222895
|Contact: Suzanne S Gisbertz, MD, PhDfirstname.lastname@example.org|
|Contact: Eliza RC Hagens, BScemail@example.com|
|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, BSc||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|