UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000121
Receipt number 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 14:13:33

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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 or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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

Value
https://center6.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