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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000121
Receipt No. R000000175
Scientific Title Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)
Date of disclosure of the study information 2005/09/06
Last modified on 2014/02/21

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Basic information
Public title Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)
Acronym Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)
Scientific Title Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)
Scientific Title:Acronym Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)
Region
Japan

Condition
Condition gastric neoplasm
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes relapse-free survival, operative morbidigy and mortality, length of postoperative hospital stay, quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A: Surgery:D2 dissection
Interventions/Control_2 B: Surgery:D2+paraaortic dissection
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key 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) mMacroscopic 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
Key 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%
Target sample size 520

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Sasako, MD
Organization National Cancer Center Hospital
Division name Gastric Surgery Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Sasako, MD
Organization JCOG9501 Coordinating Office
Division name Gastric Surgery Division, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00149279
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/18669424
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1995 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
1995 Year 07 Month 01 Day
Last follow-up date
2006 Year 04 Month 01 Day
Date of closure to data entry
2006 Year 05 Month 01 Day
Date trial data considered complete
2006 Year 05 Month 01 Day
Date analysis concluded
2006 Year 05 Month 01 Day

Other
Other related information A part of the results were published in J Clin Oncol 22:2767-2773.

Management information
Registered date
2005 Year 09 Month 06 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000175

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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