Esophageal Cancer, Gastric Cancer
Conditions
Keywords
stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer
Brief summary
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.
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.
Interventions
PROCEDUREultrasound imaging
RADIATIONradiation therapy
RADIATIONradioisotope therapy
PROCEDUREdiagnostic endoscopic procedure
PROCEDUREneoadjuvant therapy
PROCEDUREquality-of-life assessment
PROCEDUREtherapeutic conventional surgery
PROCEDUREtherapeutic endoscopic surgery
DRUGcisplatin
DRUGfluorouracil
OTHERquestionnaire administration
Sponsors
North Wales Organisation for Randomised Trials in Health
Study design
Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed