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

Phase 3
75 Years
Not Enrolling
Gastric Neoplasm

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Trial Information

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

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.

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%

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Principal Investigator

Mitsuru Sasako, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gastric Surgery Division, National Cancer Center Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

July 1995

Completion Date:

April 2006

Related Keywords:

  • Gastric Neoplasm
  • stomach neoplasms
  • lymph node excision
  • abdominal aorta
  • Neoplasms
  • Stomach Neoplasms