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Multicentric Retrospective Review of Extracapsular Lymph Node Involvement After Esophagectomy (ECLNI-MC)

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ClinicalTrials.gov Identifier: NCT01837173
Recruitment Status : Unknown
Verified April 2013 by Johnny Moons, University Hospital, Gasthuisberg.
Recruitment status was:  Enrolling by invitation
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Johnny Moons, University Hospital, Gasthuisberg

Brief Summary:

It is well known that lymph node metastasis is one of the most important prognostic factors in oesophageal carcinoma.

The investigators want to determine the influence of lymph node characteristics, being either intracapsular or extracapsular, on overall survival after esophagectomy for esophageal cancer.


Condition or disease
Cancer

Detailed Description:

The classification of carcinoma of the esophagus has undergone a major modification between the UICC sixth (TNM-6) and TNM-7 edition. Regional lymph nodes (N) are now subdivided by the number of involved lymph nodes (pN0, 0; pN1, 1-2; pN2, 3-6; pN3 > 6), and distant metastasis (M) has been simplified to M1 rather than subdivided by location [1].

Nevertheless, TNM-7 doesn't take into consideration the morphologic characteristics of the metastatic lymph node itself. Since our first publications showing a negative relationship between presence of extracapsular lymph node involvement (EC-LNI) and survival [2], little has been published about the prognostic impact of this specific characteristic .

In our latest publication "Can extracapsular lymph node involvement be a tool to fine-tune pN1 for adenocarcinoma in UICC TNM 7th Edition?" [3], the investigators found a significant survival benefit for adenocarcinoma without extracapsular lymph node involvement in pN1 (= 1-2 positive lymph nodes) as compared to N2-N3 disease, treated by primary surgery. Moreover, pN1 patients with extracapsular lymph node involvement (EC-LNI) showed a survival that was comparable to patients with more than 2 positive lymph nodes (i.e. stage IIIB). These findings may have important consequences for future TNM adaptations.

The aim of this study is to validate our results on a larger, multicentric cohort, and if possible make recommendations and possible fine-tuning for a future TNM adaptation, including the characteristics of the metastatic lymph node itself, being intra- or extracapsular.

Furthermore the investigators want to examine if these effects are valid in pre-treated patients, i.e. surgery after neoadjuvant chemo(radiation) therapy. Although these patients are not incorporated in the current TNM classification, future adaptations to the TNM classification system will also examine the effects of neoadjuvant therapy (cfr. Rice/Blackstone WECC -Worldwide Esophageal Cancer Collaboration).

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Can Extracapsular Lymph Node Involvement be a Tool to Fine-tune UICC TNM 7th Edition for Esophageal Carcinoma?
Study Start Date : March 2013
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Extracapsular LNI
Patients with positive lymph nodes that show extracapsular lymph node involvement
Intracapsular LNI
Patients with positive lymph nodes that show NO extracapsular lymph node involvement



Primary Outcome Measures :
  1. Overall survival by LN-status (being ECLNI or ICLNI) [ Time Frame: 5 yrs from surgery ]
    according UICC TNM7 pN (pN1-2-3)

  2. Cancer-specific survival by LN-status (being ECLNI or ICLNI) [ Time Frame: 5 yrs from surgery ]
    according UICC TNM7 pN (pN1-2-3)- censoring non-esophageal cancer related deaths


Secondary Outcome Measures :
  1. Cancer specific survival for intra- and extracapsular lymph node involvement [ Time Frame: 5 yrs from surgery ]
    Differentiation of intra- and extracapsular lymph node involvement after neoadjuvant chemo(radio)therapy followed by surgery versus primary surgery


Other Outcome Measures:
  1. Cancer specific survival for intra- and extracapsular lymph node involvement [ Time Frame: 5 yrs from surgery ]
    Differentiation of intra- and extracapsular lymph node involvement by histology, being Adenocarcinoma or Squamous cell carcinoma.



Information from the National Library of Medicine

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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
Multicentric cohort study, patient chart analysis Since several high volume European institutions have published their results on patients with extracapsular lymph node involvement, we plan a pooling of their 'raw' data regarding type of treatment, histology, extracapsular LNI and (disease-free) survival.
Criteria

Inclusion Criteria:

  • Adequate lymph node sampling is of paramount importance. (pT1 - min. 10 LN; >pT2 min. 20 LN resected). At least the following lymph node stations should be examined: perioesophageal distal 1/3 and perigastric LN, left gastric artery, splenic artery, common hepatic artery, subcarinal lymph nodes. Sugical technique (transthoracic, transhiatal or minimal invasive) is less important if the criterium of adequate lymph node sampling is fulfilled but should be mentioned.

Exclusion Criteria:

  • unforeseen organ metastasis
  • subcardia tumors
  • histology other than adenocarcinoma or squamous cell carcinoma
  • Postoperative (inhospital or 30-day) mortality

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): NCT01837173


Locations
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Belgium
University Hospital Leuven, Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg

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Responsible Party: Johnny Moons, RN, MSc, Datamanager, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01837173    
Other Study ID Numbers: ECLNI-MC2013
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Johnny Moons, University Hospital, Gasthuisberg:
Adenocarcinoma
Squamous Cell Carcinoma
Neoadjuvant treatment
Esophagectomy