An interventional study of cisplatin and fluorouracil in Esophageal Cancer and Gastric Cancer, sponsored by North Wales Organisation for Randomised Trials in Health. Completed at 9 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-07.
Sponsored by North Wales Organisation for Randomised Trials in Health · Not applicable, Interventional, and Diagnostic
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
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:
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 700 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →This is the only study on the registry with North Wales Organisation for Randomised Trials in Health as lead sponsor.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of gastric or esophageal cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized
Complete resection rate
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
Health resource utilization, including the selection of treatments and subsequent use of health service resources
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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