Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
Kuno Lehmann, University of Zurich
ClinicalTrials.gov Identifier:
NCT00800969
First received: November 28, 2008
Last updated: December 10, 2014
Last verified: December 2014

November 28, 2008
December 10, 2014
October 2008
January 2015   (final data collection date for primary outcome measure)
Diagnostic Accuracy of PET-CT [ Time Frame: preoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800969 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach
Not Provided

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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
  • Adenocarcinoma
  • Stomach Cancer
  • Cancer of Esophagogastric Junction
Procedure: FDG-PET-CT
Radiologic standard procedure
all patients
all patients with Adenocarcinoma
Intervention: Procedure: FDG-PET-CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
January 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11
Switzerland
 
NCT00800969
VIS-UGI-1
Not Provided
Kuno Lehmann, University of Zurich
Kuno Lehmann
Not Provided
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP