A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer
September 20, 2016 updated by: Japan Clinical Oncology Group
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
520
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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overall survival
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Secondary Outcome Measures
Outcome Measure |
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quality of life
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relapse-free survival
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operative morbidity and mortality
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length of postoperative hospital stay
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Mitsuru Sasako, MD, Gastric Surgery Division, National Cancer Center Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1200/JCO.2004.10.184. Epub 2004 Jun 15.
- 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. doi: 10.1002/bjs.7297.
- 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. doi: 10.1056/NEJMoa0707035.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1995
Primary Completion
December 7, 2022
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JCOG9501
- C000000121
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.