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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This study has been withdrawn prior to enrollment.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
November 28, 2008
December 3, 2008
June 23, 2016
October 2008
January 2015   (Final data collection date for primary outcome measure)
Diagnostic Accuracy of PET-CT [ Time Frame: preoperative ]
Same as current
Complete list of historical versions of study NCT00800969 on ClinicalTrials.gov Archive Site
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
Intervention Model: Single Group Assignment
Masking: Single (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.
 
Withdrawn
0
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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00800969
VIS-UGI-1
Not Provided
Not Provided
Not Provided
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Kuno Lehmann, MD University Hospital Zurich, Visceral surgery
University of Zurich
June 2016

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