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NCT00800969 Clinical Trial

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

Adenocarcinoma Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00800969
Other study ID # VIS-UGI-1
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 28, 2008
Last updated June 22, 2016
Start date October 2008

Study information
Verified date June 2016
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• FDG-PET-CT
Radiologic standard procedure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic Accuracy of PET-CT preoperative No
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