Status:
TERMINATED
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Gastric Neoplasm
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
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, patient...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
July 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00149266
Start Date
July 1 1995
End Date
December 1 2008
Last Update
February 3 2009
Active Locations (1)
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1
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045