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Completed

NCT Number: NCT00149279

A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

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

Completed

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Surgery: D2 dissection

Procedure

Surgery: D2+paraaortic dissection

Procedure

Primary outcomes

  1. overall survival

Secondary outcomes

  1. relapse-free survival

  2. operative morbidity and mortality

  3. length of postoperative hospital stay

  4. quality of life

Sponsors and collaborators

Lead sponsor

Japan Clinical Oncology Group

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

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

Important dates

Study start
1995
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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