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Trial record 26 of 386 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Neoplasms"

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
Sponsor:
Information provided by (Responsible Party):
S.S. Gisbertz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 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
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Distribution of Lymph Node Metastases in Esophageal Carcinoma
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Prognostic value of different lymph node stations [ Time Frame: 2 years ]
    Prognostic value of different lymph node stations

  3. 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

  4. 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

  5. Skip nodal metastases [ Time Frame: 2 years ]
    Analysis of the phenomenon skip nodal metastases

  6. Ratio of nodal metastases inside and outside the radiation field [ Time Frame: 2 years ]
    Ratio of nodal metastases inside and outside the radiation field

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Suzanne S Gisbertz, MD, PhD +31205669111 s.s.gisbertz@amc.nl
Contact: Eliza RC Hagens, BSc +31613460431 e.r.hagens@amc.uva.nl

Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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)

Responsible Party: S.S. Gisbertz, Upper GI Surgeon, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03222895     History of Changes
Other Study ID Numbers: W17_069
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by S.S. Gisbertz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Esophageal Neoplasms
Lymph node metastases
Esophagectomy

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases