Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach

NCT ID: NCT00800969

Last Updated: 2016-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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This prospective study includes patients with histologically proven cancer of the esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is performed and individual lymph node stations (Nr 1-12 according to the Japanese classification) are histopathologically examined. Furthermore we evaluate the role of the PET-CT for early metabolic response evaluation in patients receiving neoadjuvant chemotherapy.

* Trial with surgical intervention

Detailed Description

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Conditions

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Adenocarcinoma Stomach Cancer Cancer of Esophagogastric Junction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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all patients

all patients with Adenocarcinoma

Group Type OTHER

FDG-PET-CT

Intervention Type PROCEDURE

Radiologic standard procedure

Interventions

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FDG-PET-CT

Radiologic standard procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histological prove of adenocarcinoma of the stomach.

Exclusion Criteria

* Recurrent gastric carcinoma
* No informed consent
* Previous malignancy (exception: thyroid, bladder in situ, Cervix in situ)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuno Lehmann, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Visceral surgery

Locations

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Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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VIS-UGI-1

Identifier Type: -

Identifier Source: org_study_id

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