UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000059
Receipt number R000000104
Scientific Title Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Date of disclosure of the study information 2005/08/15
Last modified on 2014/02/21 13:54:42

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)

Acronym

Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)

Scientific Title

Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)

Scientific Title:Acronym

Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)

Region

Japan


Condition

Condition

gastric neoplasm

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

False-negative rate

Key secondary outcomes

Success rate, false-positive rate, post-operative morbidity, anaphylaxis reaction, relapse-free survival of patients with lymph node metastases


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Gastrectomy with extemded lymphadenectomy after sentinel node biopsy

Interventions/Control_2


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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Preoperatively,
(1) histologically proven adenocarcinoma,
(2)T1, and 4cm or less in diameter, no tumor within 2cm from esophagogastric junction or pyloric ring,
(3) no existence of multiple foci,
(4) no prior treatment for gastric cancer,
(5) no prior surgery for gastric or duodenal ulcer
(6) written informed consent.
Intra-operatively,
(7) prior to dye injection,
(8) not laparoscopic surgery,
(9) T1,
(10) palpable of tumor or marking clips,
(11) no apparent lymph node metastasis,
(12) no severe adhesion around stomach.

Key exclusion criteria

(1) anaphylaxis reaction against iodine,
(2) non-curative synchronous malignancy.

Target sample size

1550


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Hiratsuka, MD, PhD

Organization

Itami municipal hospital

Division name

Surgery

Zip code


Address

1-100 Koyaike, Itami, Hyogo 664-8540, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Isao Miyashiro, MD, PhD

Organization

JCOG0302 Coordinating Office

Division name

Gastric Surgery Division, Osaka Medical Center for Cancer and Cardiovascular Diseases

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, 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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

岩手医科大学(岩手県)
国立病院機構仙台医療センター(宮城県)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)
都立駒込病院(東京都)
都立墨東病院(東京都)
神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
燕労災病院(新潟県)
富山県立中央病院(富山県)
岐阜市民病院(岐阜県)
愛知県がんセンター中央病院 (愛知県)
京都第2赤十字病院(京都府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪医科大学(大阪府)
市立豊中病院(大阪府)
市立堺病院(大阪府)
市立伊丹病院(兵庫県)
和歌山県立医科大学(和歌山県)
広島市立広島市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)


Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23933782

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

Terminated

Date of protocol fixation

2004 Year 01 Month 13 Day

Date of IRB


Anticipated trial start date

2004 Year 05 Month 01 Day

Last follow-up date

2012 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 08 Month 15 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=R000000104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name