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

History of Changes

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:

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

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,

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%

Contacts and Locations

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Sano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004 Jul 15;22(14):2767-73. Epub 2004 Jun 15.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45.

Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62.

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
Gastrointestinal Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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