Back to resultsProspective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach
Primary Purpose
Adenocarcinoma, Stomach Cancer, Cancer of Esophagogastric Junction
Status
Withdrawn
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
FDG-PET-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenocarcinoma focused on measuring Adenocarcinoma of the stomach and esophagogastric junction
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
all patients
Arm Description
all patients with Adenocarcinoma
Outcomes
Primary Outcome Measures
Diagnostic Accuracy of PET-CT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00800969
Brief Title
Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Stomach Cancer, Cancer of Esophagogastric Junction
Keywords
Adenocarcinoma of the stomach and esophagogastric junction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
all patients
Arm Type
Other
Arm Description
all patients with Adenocarcinoma
Intervention Type
Procedure
Intervention Name(s)
FDG-PET-CT
Intervention Description
Radiologic standard procedure
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of PET-CT
Time Frame
preoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuno Lehmann, MD
Organizational Affiliation
University Hospital Zurich, Visceral surgery
Official's Role
Principal Investigator
Facility Information:
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach
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