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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004995
Receipt No. R000005789
Scientific Title Single-arm confirmatory study of endoscopic submucosal dissection for expand indication to early gastric cancer of undifferentiated type (JCOG1009/1010, Undiff GC ESD)
Date of disclosure of the study information 2011/02/01
Last modified on 2015/04/03

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Basic information
Public title Single-arm confirmatory study of endoscopic submucosal dissection for expand indication to early gastric cancer of undifferentiated type (JCOG1009/1010, Undiff GC ESD)
Acronym Single-arm confirmatory study of endoscopic submucosal dissection for expand indication to early gastric cancer of undifferentiated type (JCOG1009/1010, Undiff GC ESD)
Scientific Title Single-arm confirmatory study of endoscopic submucosal dissection for expand indication to early gastric cancer of undifferentiated type (JCOG1009/1010, Undiff GC ESD)
Scientific Title:Acronym Single-arm confirmatory study of endoscopic submucosal dissection for expand indication to early gastric cancer of undifferentiated type (JCOG1009/1010, Undiff GC ESD)
Region
Japan

Condition
Condition clinical T1a (M) gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) for intramucosal gastric cancer of undifferentiated type.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes % 5-year overall survival in patients with undifferentiated dominant type diagnosed in the ESD specimen.
Key secondary outcomes OS, relapse-free survival (RFS), distant metastasis-free survival, % 5-year survival without either reccurece or gastrectomy, % enbloc resection with ESD, % pathological curative resection with ESD, % 5-year OS in patients with differentiated dominant type diagnosed in the ESD specimen, % 5-year OS in patients with pathological curative resection with ESD, adverse events, serious adverse events

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic submucal dissection (Patients with non-curative resection by ESD undergo additional gastrectomy)
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 1) Histologically proven components of undifferentiated adenocarcinoma (por or sig).
2) Negative result of endoscopic biopsy around the lesion, which should be examined in the participating institution.
3) Non-recurrence and single tumor.
4) Clinical T1a (M)
5) Size of tumor is <= 2cm.
6) UL(-) in endoscopic findings.
7) The possibility of stenosis after ESD is low.
8) Clinical N0/M0 by abdominal CT.
9) Aged 20 to 80 years old.
10) PS (ECOG) of 0 or 1.
11) No gastrectomy and no reconstructive surgery of stomach tube for esophageal cancer.
12) No prior treatment of chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies.
13) Sufficient organ functions.
14) Written informed consent.
Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Body temperature of 38 or more degrees Celsius.
4) Women during pregnancy or breast-feeding.
5) Psychosis.
6) Systemic steroids medication.
7) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks.
8) Uncontrollable hypertension.
9) Severe respiratory disease requiring continuous oxygen therapy.
10) Impossible to suspend anticoagulant or antiplatelet medications.
11) Uncontrollable diabetes millutus or administration of insulin.
Target sample size 325

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Ono
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-Gun, Shizuoka 411-8777, JAPAN
TEL 055-989-5222(2270)
Email h.ono@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Takizawa
Organization JCOG1009/1010 Coordinating Office
Division name Division of Endoscopy, Shizuoka Cancer Center
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-Gun, Shizuoka 411-8777, JAPAN
TEL 055-989-5222
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 恵佑会札幌病院(北海道)
岩手医科大学(岩手県)
岩手県立中央病院(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)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
総合病院国保旭中央病院(千葉県)
国立がん研究センター中央病院(東京都)
昭和大学病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
NTT東日本関東病院(東京都)
都立墨東病院(東京都)
神奈川県立病院機構(神奈川県)
横浜市立市民病院(神奈川県)
北里大学医学部(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
新潟大学医歯学総合病院(新潟県)
新潟県立がんセンター新潟病院(新潟県)
富山県立中央病院(富山県)
石川県立中央病院(石川県)
佐久総合病院(長野県)
岐阜大学医学部(岐阜県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
静岡県立総合病院(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
国立病院機構京都医療センター(京都府)
大阪府立病院機構(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
大阪大学医学部(大阪府)
近畿大学医学部(大阪府)
国立病院機構大阪医療センター(大阪府)
市立堺病院(大阪府)
関西医科大学附属枚方病院(大阪府)
神戸大学医学部(兵庫県)
兵庫医科大学(兵庫県)
兵庫県立がんセンター(兵庫県)
医療法人薫風会佐野病院(兵庫県)
関西労災病院(兵庫県)
市立伊丹病院(兵庫県)
天理よろづ相談所病院(奈良県)
和歌山県立医科大学(和歌山県)
島根大学医学部(島根県)
広島市立広島市民病院(広島県)
広島市立安佐市民病院(広島県)
福山市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2010 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2023 Year 05 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 01 Day
Last modified on
2015 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005789

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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