Endoscopic Ultrasound 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.

• cisplatin (Drug)
• fluorouracil (Drug)
• questionnaire administration (Other)
• diagnostic endoscopic procedure (Procedure)
• neoadjuvant therapy (Procedure)
• quality-of-life assessment (Procedure)
• therapeutic conventional surgery (Procedure)
• therapeutic endoscopic surgery (Procedure)
• ultrasound imaging (Procedure)
• radiation therapy (Radiation)
• radioisotope therapy (Radiation)

Primary outcomes

• Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized

Secondary outcomes

• 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

Sex: All, ages: 18 Years to any

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

• Ken Park, MD, Study chair, North Wales Organisation for Randomised Trials in Health