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

Sponsor

North Wales Organisation for Randomised Trials in Health (Other)

Overall Status

Completed

CT.gov ID

NCT00629863

Collaborator

(none)

700

Enrollment

Locations

Duration (Months)

77.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: cisplatin Drug: fluorouracil Other: questionnaire administration Procedure: diagnostic endoscopic procedure Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Procedure: therapeutic endoscopic surgery Procedure: ultrasound imaging Radiation: radiation therapy Radiation: radioisotope therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Blackburn Hospital	Blackburn	England	United Kingdom	BB2 3 HH
2	Gloucestershire Royal Hospital	Gloucester	England	United Kingdom	GL1 3NN
3	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
4	North Tyneside Hospital	North Shields	England	United Kingdom	NE29 8NH
5	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
6	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
7	Ninewells Hospital	Dundee	Scotland	United Kingdom	DD1 9SY
8	Royal Infirmary - Castle	Glasgow	Scotland	United Kingdom	G4 0SF
9	North Wales Organisation for Randomised Trials in Health	Bangor	Wales	United Kingdom	LL57 2PZ