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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149279

Locations
Japan
National Cancer Center Hospital
5-1-1 Tsukiji, 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:
Additional 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
Study First Received: September 7, 2005
Last Updated: May 31, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
stomach neoplasms
lymph node excision
abdominal aorta

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014