A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Japan Clinical Oncology Group520 enrolled

Overview

To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

520

Conditions

Gastric Neoplasm

Interventions

Surgery: D2 dissectionPROCEDURE

Surgery: D2+paraaortic dissectionPROCEDURE

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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%

Locations (1)

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

overall survival

Secondary Outcomes

relapse-free survival

operative morbidity and mortality

length of postoperative hospital stay

quality of life

Data from ClinicalTrials.gov

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