NCT00800969

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

6.3 years

First QC Date

November 28, 2008

Last Update Submit

June 22, 2016

Conditions

AdenocarcinomaStomach CancerCancer of Esophagogastric Junction

Keywords

Adenocarcinoma of the stomach and esophagogastric junction

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of PET-CT

    preoperative

Study Arms (1)

all patients

OTHER

all patients with Adenocarcinoma

Procedure: FDG-PET-CT

Interventions

FDG-PET-CTPROCEDURE

Radiologic standard procedure

all patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological prove of adenocarcinoma of the stomach.

You may not qualify if:

  • Recurrent gastric carcinoma
  • No informed consent
  • Previous malignancy (exception: thyroid, bladder in situ, Cervix in situ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

AdenocarcinomaStomach Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Kuno Lehmann, MD

    University Hospital Zurich, Visceral surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2008

First Posted

December 3, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2015

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

CH(1)