Clinical trial NCT00629863: Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer
Official title: Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-03-06
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized
Secondary outcomes:
measure: Complete resection rate
measure: 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
measure: Health resource utilization, including the selection of treatments and subsequent use of health service resources
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: England
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: North Shields
country: United Kingdom
facility: North Tyneside Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Infirmary - Castle
state: Scotland
city: Bangor
country: United Kingdom
facility: North Wales Organisation for Randomised Trials in Health
state: Wales
Study officials:
affiliation: North Wales Organisation for Randomised Trials in Health
name: Ken Park, MD
role: STUDY_CHAIR
References: