CancerECLNI-MCNCT01837173
Multicentric Retrospective Review of Extracapsular Lymph Node Involvement After Esophagectomy
An observational study of Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- unforeseen organ metastasis
- subcardia tumors
- histology other than adenocarcinoma or squamous cell carcinoma
- Postoperative (inhospital or 30-day) mortality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Extracapsular Lymph Node Involvement be a Tool to Fine-tune UICC TNM 7th Edition for Esophageal Carcinoma?
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.
Read the 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).
- Conditions
- Cancer
- Keywords
- Adenocarcinoma, Squamous Cell Carcinoma, Neoadjuvant treatment, Esophagectomy
- Medical subject headings
- Neoplasms, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival by LN-status (being ECLNI or ICLNI)
according UICC TNM7 pN (pN1-2-3)
Measured: 5 yrs from surgery
Cancer-specific survival by LN-status (being ECLNI or ICLNI)
according UICC TNM7 pN (pN1-2-3)- censoring non-esophageal cancer related deaths
Measured: 5 yrs from surgery
Secondary outcomes (1)
Cancer specific survival for intra- and extracapsular lymph node involvement
Differentiation of intra- and extracapsular lymph node involvement after neoadjuvant chemo(radio)therapy followed by surgery versus primary surgery
Measured: 5 yrs from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Moons, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837173
- Sponsor's protocol ID
- ECLNI-MC2013
- Acronym
- ECLNI-MC
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Extracapsular Lymph Node Involvement be a Tool to Fine-tune UICC TNM 7th Edition for Esophageal Carcinoma?
- ClinicalTrials.gov ID
- NCT01837173
- Acronym / sponsor ID
- ECLNI-MC / ECLNI-MC2013
- Conditions
- Cancer
- Keywords
- Adenocarcinoma, Squamous Cell Carcinoma, Neoadjuvant treatment, Esophagectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- unforeseen organ metastasis
- subcardia tumors
- histology other than adenocarcinoma or squamous cell carcinoma
- Postoperative (inhospital or 30-day) mortality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival by LN-status (being ECLNI or ICLNI)
Time frame: 5 yrs from surgery
according UICC TNM7 pN (pN1-2-3)
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
1 secondary outcome
Cancer specific survival for intra- and extracapsular lymph node involvement
Time frame: 5 yrs from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival by LN-status (being ECLNI or ICLNI) (time frame: 5 yrs from surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.