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

Gastric Cancer Clinical Trial

Official title:

Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629863
• Other study ID #: NWORTH-COGNATE
• Secondary ID: CDR0000584174ISR
• Status: Completed
• Phase: N/A
• First received: March 5, 2008
• Last updated: August 6, 2013
• Start date: September 2004
• Est. completion date: January 2010

Study information

• Verified date: January 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Other:
• questionnaire administration

Procedure:
• diagnostic endoscopic procedure

• neoadjuvant therapy

• quality-of-life assessment

• therapeutic conventional surgery

• therapeutic endoscopic surgery

• ultrasound imaging

Radiation:
• radiation therapy

• radioisotope therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	North Wales Organisation for Randomised Trials in Health	Bangor	Wales
United Kingdom	Royal Blackburn Hospital	Blackburn	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	Gloucestershire Royal Hospital	Gloucester	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	North Tyneside Hospital	North Shields	England
United Kingdom	Southampton General Hospital	Southampton	England

Sponsors (1)

Lead Sponsor	Collaborator
North Wales Organisation for Randomised Trials in Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized			No
Secondary	Complete resection rate			No
Secondary	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			No
Secondary	Health resource utilization, including the selection of treatments and subsequent use of health service resources			No