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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus

Rekrutierend

NCT-Nummer:
NCT04818476

Studienbeginn:
Februar 2020

Letztes Update:
26.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma, Barrett Esophagus, Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborator:
-

Studienleiter

R.E. Pouw, MD, PhD
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Kontakt

Studienlocations
(3 von 16)

Amsterdam UMC, location VUmc
Amsterdam
NetherlandsAbgeschlossen» Google-Maps
University Medical Center Groningen
Groningen
NetherlandsAbgeschlossen» Google-Maps
Erasmus MC - University Medical Center
Rotterdam
NetherlandsAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The incidence of esophageal adenocarcinoma (EAC) has increased six-fold over the last three

decades, making it the most rapidly rising cancer in the Western world. The main histologic

risk factor for development of EAC is the presence of Barrett's esophagus (BE). BE can

develop from non-dysplastic BE, to low (LGD) and high grade dysplasia (HGD) and, eventually,

EAC.

The past two decades minimally invasive endoscopic resection (ER) has replaced surgical

esophagectomy as first-choice therapy for the treatment of early neoplastic lesions in

Barrett's esophagus. ER provides adequate tissue specimens, allowing for accurate

histopathological staging of a lesion, by assessment of invasion depth, differentiation

grade, presence of lympho-vascular invasion (LVI), and radicality of the resection.

Endoscopic resection thus similarly fulfils a diagnostic and therapeutic role in the

management of Barrett's neoplasia.

However, ER offers local treatment and does not include lymph node dissection as is still

standard of care during esophagectomy. Therefore, the choice to perform endoscopic follow-up

after a radical ER of an early EAC, or to refer a patient for additional surgery, is guided

by the assumed risk of lymph node metastasis (LNM).

Data from previous studies show that the risk of LNM is only 1% in patients with low risk

mucosal EAC after endoscopic treatment (i.e., infiltration depth limited to the mucosa,

G1-G2, without LVI), and <2% in low risk submucosal EAC (i.e., infiltration depth <500μm,

good to moderate differentiation grade (G1-G2), without LVI). In high risk submucosal EAC

(i.e., infiltration depth ≥500 μm, and/or G3-G4, and/or LVI), the LNM risk is estimated to be

much higher (16-44%). Nevertheless, these numbers are mainly based on old surgical series.

Current data is limited in terms of small and heterogeneous patient cohorts, and data for

patients with high risk T1a EAC is not available at all. Therefore, we would like to conduct

an international multicenter retrospective cohort study in >10 centers to evaluate the safety

and efficacy of endoscopic treatment and follow-up of patients with high risk mucosal and

submucosal EAC. Our main focus will be the presence of lymph node metastasis and EAC related

death.

Aim of this registration study is to collect data of the above-mentioned group of patients

and thereby assess lymph node metastasis rate, disease-specific mortality, and overall

mortality.

This study will be conducted according to the principles of the Declaration of Helsinki and

in accordance with the Medical Research Involving Human Subjects Act (WMO), the Medical

Treatment Contracts Act (WGBO) and the Dutch Personal Data Protection Act (WBP). The

investigators will perform the study in accordance with this protocol and will make sure that

participants do not object to using their data. Collection, recording, and reporting of data

will be accurate and will ensure the privacy, health, and welfare of research subjects during

and after the study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Males or females, all ages

2. Endoscopic resection of a histologically proven high risk T1a, low risk T1b EAC, or

high risk T1b EAC

3. Between 1/1/2008 and 1/1/2019

4. Endoscopic resection and endoscopic FU (or other treatment after ER) have taken place

in the participating center

5. No written or oral refusal to use subject's data

Exclusion Criterium:

Objection against participation in this study

Studien-Rationale

Primary outcome:

1. lymph node metastasis rate (Time Frame - 10 years):
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies

2. distant metastasis rate (Time Frame - 10 years):
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.

3. disease-specific mortality (Time Frame - 10 years):
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.

4. overall mortality (Time Frame - 10 years):
Overall mortality of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).

Studien-Arme

  • HR-T1a
    Patients who weretreated by radical endoscopic resection for a high-risk mucosal EAC (HR-T1a N0M0)
  • LR-T1b
    Patients who were treated by radical endoscopic resection for a low-risk submucosal EAC (LR-T1b N0M0)
  • HR-T1b
    Patients who were treated by radical endoscopic resection for a high-risk submucosal EAC (HR-T1b N0M0)

Geprüfte Regime

  • diagnostic endoscopic resection:
    diagnostic endoscopic resection

Quelle: ClinicalTrials.gov


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