A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

J

Japan Clinical Oncology Group

Status and phase

Completed
Phase 3

Conditions

Gastric Neoplasm

Treatments

Procedure: Surgery: D2+paraaortic dissection
Procedure: Surgery: D2 dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT00149279
C000000121
JCOG9501

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- 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 criteria

  • 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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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