Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
Phase 3
Terminated
- Conditions
- Gastric Neoplasm
- Registration Number
- NCT00149266
- Lead Sponsor
- Japan Clinical Oncology Group
- Brief Summary
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer
- Detailed Description
For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 167
Inclusion Criteria
- histologically proven adenocarcinoma
- 75 years old or younger
- forced expiratory volume in one second ≥ 50 %
- arterial oxygen pressure in room air ≥ 70 mmHg
- clinically T2/T3/T4 with ≤3 cm esophageal invasion
- written consent
Exclusion Criteria
- Carcinoma in the remnant stomach
- Borrmann type 4 (linitis plastica)
- synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
- history of left thoracotomy, or left pleural adhesion
- past history of myocardial infarction or positive results of exercise ECG
- liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method relapse-free survival operative morbidity and mortality quality of life
Trial Locations
- Locations (1)
National Cancer Center Hospital
🇯🇵5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan