A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer
Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)
2 other identifiers
interventional
520
1 country
1
Brief Summary
To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 1995
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1995
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedSeptember 22, 2016
September 1, 2016
September 7, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
Secondary Outcomes (4)
relapse-free survival
operative morbidity and mortality
length of postoperative hospital stay
quality of life
Interventions
Eligibility Criteria
You may qualify if:
- \- Preoperatively,
- histologically proven adenocarcinoma
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Related Publications (3)
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.
PMID: 15199090BACKGROUNDKurokawa 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.
PMID: 21104822DERIVEDSasako 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.
PMID: 18669424DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mitsuru Sasako, MD
Gastric Surgery Division, National Cancer Center Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
July 1, 1995
Study Completion
April 1, 2006
Last Updated
September 22, 2016
Record last verified: 2016-09