COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149279
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 22, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment Phase
Gastric Neoplasm Procedure: Surgery: D2 dissection Procedure: Surgery: D2+paraaortic dissection Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)
Study Start Date : July 1995
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. relapse-free survival
  2. operative morbidity and mortality
  3. length of postoperative hospital stay
  4. quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149279

Layout table for location information
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Layout table for investigator information
Study Chair: Mitsuru Sasako, MD Gastric Surgery Division, National Cancer Center Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00149279    
Other Study ID Numbers: JCOG9501
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Japan Clinical Oncology Group:
stomach neoplasms
lymph node excision
abdominal aorta
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases