Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer
NCT ID: NCT00629863
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
700 participants
INTERVENTIONAL
2004-09-30
2010-01-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
DIAGNOSTIC
Interventions
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cisplatin
fluorouracil
questionnaire administration
diagnostic endoscopic procedure
neoadjuvant therapy
quality-of-life assessment
therapeutic conventional surgery
therapeutic endoscopic surgery
ultrasound imaging
radiation therapy
radioisotope therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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North Wales Organisation for Randomised Trials in Health
OTHER
Principal Investigators
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Ken Park, MD
Role: STUDY_CHAIR
North Wales Organisation for Randomised Trials in Health
Locations
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Royal Blackburn Hospital
Blackburn, England, United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
North Tyneside Hospital
North Shields, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
North Wales Organisation for Randomised Trials in Health
Bangor, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000584174
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN01444215
Identifier Type: -
Identifier Source: secondary_id
NWORTH-04/MRE10/10
Identifier Type: -
Identifier Source: secondary_id
NWORTH-COGNATE
Identifier Type: -
Identifier Source: org_study_id