Trial Information

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

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.