Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 18
- 主要终点
- Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized
次要结局
- 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