Trial | NCT00629863  Report issue

Title

Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer
Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluorouracil 125-iodine cisplatin ...

  • Study Participants

    700
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.
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 Started
Sep 30
2004
Primary Completion
Sep 30
2009
Study Completion
Jan 31
2010
Last Update
Aug 07
2013
Estimate

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

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
No Results Posted