Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Interventions

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cisplatin

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

questionnaire administration

Intervention Type OTHER

diagnostic endoscopic procedure

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

therapeutic endoscopic surgery

Intervention Type PROCEDURE

ultrasound imaging

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

radioisotope therapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No