Status:
COMPLETED
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer
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 evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy
Detailed Description
Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials...
Eligibility Criteria
Inclusion
- \- Preoperatively,
- histologically proven adenocarcinoma
- 75 years old or younger
- forced expiratory volume in one second ≥ 50 %
- arterial oxygen pressure in room air ≥ 70 mmHg
- creatinine clearance ≥ 50 ml/min
- written consent. Intraoperatively
- Macroscopic T staging is T2-subserosa, T3, or T4
- potentially curative operation is possible
- no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed)
- peritoneal lavage cytology is negative for cancer cells
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
- past history of myocardial infarction or positive results of exercise ECG
- liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%
Key Trial Info
Start Date :
July 1 1995
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00149279
Start Date
July 1 1995
End Date
April 1 2006
Last Update
September 22 2016
Active Locations (1)
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1
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045