Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer
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.
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 Design:||Allocation: Randomized
Primary Purpose: Diagnostic
|Official Title:||Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE|
- Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||September 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629863
|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|
|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|
|Study Chair:||Ken Park, MD||North Wales Organisation for Randomised Trials in Health|