Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer

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. Identifier: NCT00629863
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer.

PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: cisplatin Drug: fluorouracil Other: questionnaire administration Procedure: diagnostic endoscopic procedure Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Procedure: therapeutic endoscopic surgery Procedure: ultrasound imaging Radiation: radiation therapy Radiation: radioisotope therapy Not Applicable

Detailed Description:



  • To determine the additional effect of endoscopic ultrasound (EUS) staging compared with a standard staging algorithm on the selection of treatment in patients with gastric or esophageal cancer (GOC), including the numbers of patients treated surgically, with multimodality therapy, or with non-surgical means.
  • To estimate the effect of EUS staging on the outcome of care of these patients.
  • To assess the cost-effectiveness of EUS by comparing improvements in patient outcomes with the additional costs of the procedure.
  • To estimate the proportion of patients with GOC who will benefit from EUS and therefore to determine the need for EUS facilities within a population.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor location (gastric vs esophageal vs gastroesophageal junction) and participating center.

All patients undergo standard staging methods. Patients with localized tumors are randomized to undergo either endoscopic ultrasound (EUS) or no further staging. Both groups receive treatment as follows, depending on the type of tumor:

  • Mucosal tumors: Patients undergo endoscopic mucosal resection and argon-beam ablation of the surrounding mucosa.
  • Resectable tumors: Patients undergo surgery and neoadjuvant chemotherapy comprising cisplatin and fluorouracil.
  • Advanced localized disease without the possibility of complete resection: Patients receive chemoradiotherapy or chemotherapy alone depending upon the site. Patients with gastric cancer may undergo palliative surgery.

Quality of life is assessed at 1, 3, 6, 12, 18, and 24 months using questionnaires, including the EuroQol EQ-5D, the EORTC core module QLQ-C30, the EORTC esophageal module QLQ-OES24, and the EORTC gastric module QLQ-STO22.

After completion of study treatment, patients are followed every 3 months for a minimum of 1 year.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Primary Purpose: Diagnostic
Official Title: Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE
Study Start Date : September 2004
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized

Secondary Outcome Measures :
  1. Complete resection rate
  2. Quality of survival in the different treatments selected on the basis of staging at 1, 3, 6, 12, 18, and 24 months by EuroQol EQ-5D, EORTC core module QLQ-C30, EORTC esophageal module QLQ-OES24, and EORTC gastric module QLQ-STO22
  3. Health resource utilization, including the selection of treatments and subsequent use of health service resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of gastric or esophageal cancer

    • Localized disease
    • No metastatic disease


  • WHO performance status 0-2
  • American Society of Anesthesiologists grade 1 (no physiological disturbance) or 2 (minor well-compensated physiological impairment)
  • Must be fit for surgery and chemotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629863

United Kingdom
Royal Blackburn Hospital
Blackburn, England, United Kingdom, BB2 3 HH
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom, GL1 3NN
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
North Tyneside Hospital
North Shields, England, United Kingdom, NE29 8NH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
North Wales Organisation for Randomised Trials in Health
Bangor, Wales, United Kingdom, LL57 2PZ
Sponsors and Collaborators
North Wales Organisation for Randomised Trials in Health
Study Chair: Ken Park, MD North Wales Organisation for Randomised Trials in Health Identifier: NCT00629863     History of Changes
Other Study ID Numbers: NWORTH-COGNATE
CDR0000584174 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: January 2009

Keywords provided by National Cancer Institute (NCI):
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs