A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Neoplasm

• Registration Number: NCT00149279
• Lead Sponsor: Japan Clinical Oncology Group

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 only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Study Completion: 2006-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Preoperatively,

1. histologically proven adenocarcinoma
2. 75 years old or younger
3. forced expiratory volume in one second ≥ 50 %
4. arterial oxygen pressure in room air ≥ 70 mmHg
5. creatinine clearance ≥ 50 ml/min
6. written consent. Intraoperatively
7. Macroscopic T staging is T2-subserosa, T3, or T4
8. potentially curative operation is possible
9. no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed)
10. peritoneal lavage cytology is negative for cancer cells

Exclusion Criteria

1. Carcinoma in the remnant stomach
2. Borrmann type 4 (linitis plastica)
3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
4. past history of myocardial infarction or positive results of exercise ECG
5. liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%

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
length of postoperative hospital stay
quality of life

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan