A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149279

Enrollment

520

Registered

2005-09-08

Start date

1995-07-31

Completion date

2006-04-30

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Neoplasm

Keywords

stomach neoplasms, lymph node excision, abdominal aorta

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.

Interventions

PROCEDURESurgery: D2 dissection

PROCEDURESurgery: D2+paraaortic dissection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
relapse-free survival	—
operative morbidity and mortality	—
length of postoperative hospital stay	—
quality of life	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026