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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00629863
First received: March 5, 2008
Last updated: August 6, 2013
Last verified: January 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Diagnostic
Official Title: Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete resection rate [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Health resource utilization, including the selection of treatments and subsequent use of health service resources [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: September 2004
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of gastric or esophageal cancer

    • Localized disease
    • No metastatic disease

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629863

Locations
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
Investigators
Study Chair: Ken Park, MD North Wales Organisation for Randomised Trials in Health
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00629863     History of Changes
Other Study ID Numbers: NWORTH-COGNATE, CDR0000584174, ISRCTN01444215, NWORTH-04/MRE10/10
Study First Received: March 5, 2008
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

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:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014