UMIN-CTR Clinical Trial

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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