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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800969
First Posted: December 3, 2008
Last Update Posted: June 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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

Condition Intervention Phase
Adenocarcinoma Stomach Cancer Cancer of Esophagogastric Junction Procedure: FDG-PET-CT Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Diagnostic Accuracy of PET-CT [ Time Frame: preoperative ]

Enrollment: 0
Study Start Date: October 2008
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
all patients
all patients with Adenocarcinoma
Procedure: FDG-PET-CT
Radiologic standard procedure

  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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): NCT00800969


Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Kuno Lehmann, MD University Hospital Zurich, Visceral surgery
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00800969     History of Changes
Other Study ID Numbers: VIS-UGI-1
First Submitted: November 28, 2008
First Posted: December 3, 2008
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by University of Zurich:
Adenocarcinoma of the stomach and esophagogastric junction

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases