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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

March 5, 2008
August 6, 2013
September 2004
September 2009   (final data collection date for primary outcome measure)
Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized [ Designated as safety issue: No ]
Overall survival at 12 months for patients last randomized and at 48 months for patients first randomized [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00629863 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer
Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Diagnostic
  • 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 Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
January 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00629863
NWORTH-COGNATE, CDR0000584174, ISRCTN01444215, NWORTH-04/MRE10/10
Not Provided
Not Provided
North Wales Organisation for Randomised Trials in Health
Not Provided
Study Chair: Ken Park, MD North Wales Organisation for Randomised Trials in Health
National Cancer Institute (NCI)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP