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A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149279
First Posted: September 8, 2005
Last Update Posted: September 22, 2016
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.
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
  Purpose
To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

Condition Intervention Phase
Gastric Neoplasm Procedure: Surgery: D2 dissection Procedure: Surgery: D2+paraaortic dissection Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • relapse-free survival
  • operative morbidity and mortality
  • length of postoperative hospital stay
  • quality of life

Estimated Enrollment: 520
Study Start Date: July 1995
Estimated Study Completion Date: April 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00149279


Locations
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Mitsuru Sasako, MD Gastric Surgery Division, National Cancer Center Hospital
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149279     History of Changes
Other Study ID Numbers: JCOG9501
C000000121
First Submitted: September 7, 2005
First Posted: September 8, 2005
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:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases