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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00800969
First received: November 28, 2008
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Diagnostic Accuracy of PET-CT [ Time Frame: preoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: FDG-PET-CT
    Radiologic standard procedure
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800969

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00800969     History of Changes
Other Study ID Numbers: VIS-UGI-1
Study First Received: November 28, 2008
Last Updated: February 2, 2010
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on June 18, 2013