A Trial to Evaluate Para-Aortic Lymphadenectomy for Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00149279
First received: September 7, 2005
Last updated: May 31, 2007
Last verified: May 2007

September 7, 2005
May 31, 2007
July 1995
Not Provided
overall survival
Same as current
Complete list of historical versions of study NCT00149279 on ClinicalTrials.gov Archive Site
  • relapse-free survival
  • operative morbidity and mortality
  • length of postoperative hospital stay
  • quality of life
Same as current
Not Provided
Not Provided
 
A Trial to Evaluate Para-Aortic Lymphadenectomy for Gastric Cancer
Randomized Controlled Trial to Evaluate Para-Aortic Lymphadenectomy for Gastric Cancer (JCOG9501)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Neoplasm
  • Procedure: Surgery: D2 dissection
  • Procedure: Surgery: D2+paraaortic dissection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
520
April 2006
Not Provided

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%
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00149279
JCOG9501, C000000121
Yes
Not Provided
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Mitsuru Sasako, MD Gastric Surgery Division, National Cancer Center Hospital
Japan Clinical Oncology Group
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP