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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000737
Receipt No. R000000885
Scientific Title Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Date of disclosure of the study information 2007/06/08
Last modified on 2017/03/23

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Basic information
Public title Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Acronym Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Scientific Title Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Scientific Title:Acronym Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Region
Japan

Condition
Condition clinical T1 gastric cancer without submucosal invasion
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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 5-year overall survival (OS)
Key secondary outcomes OS in UL(-) cases, OS in UL(+) cases, recurrence-free survival (RFS), 5-year RFS with stomach, proportion of one-piece resection, proportion of pathological curative resection after EMR, 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 with or without surgical gastrectomy after histological findings.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven differentiated adenocarcinoma by biopsy. A mixed case of undifferentiated components is not eligible.
2) Non-recurrence and single tumor.
3) Clinical T1 tumor without submucosal invasion.
4) Size of tumor is >2cm in a UL(-) case or &#8804;3cm in a UL(+) case.
5) One-piece resection is possible with ESD.
6) The possibility of stenosis after EMR is low.
7) Clinical N0/M0 by abdominal CT.
8) Aged 20 to 75 years old.
9) PS (ECOG) of 0 or 1.
10) No gastrectomy and endoscopic treatment for simultaneous or metachronous gastric cancer, and no reconstructive surgery of stomach tube for esophageal cancer.
11) No prior treatment of chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies.
12) Sufficient organ functions.
13) Written informed consent.
Key exclusion criteria 1) Impossible to discontinue anticoagulant or antiplatelet medications.
2) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy.
3) Women during pregnancy or breast-feeding.
4) Psychosis.
5) Systemic steroids medication.
6) Active bacterial or fungous infection.
7) History of myocardial infarction or unstable angina pectoris within three months.
8) Uncontrollable hypertension.
9) Uncontrollable diabetes mellitus or administration of insulin.
10) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size 470

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narikazu Boku
Organization Sizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka 411-8777, JAPAN
TEL 055-989-5222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Ono
Organization JCOG0607 Coordinating Office
Division name Division of Endoscopy, Shizuoka Cancer Center
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, 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 北海道大学病院(北海道)
斗南病院(北海道)
岩手県立中央病院(岩手県)
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)
自治医科大学(栃木県)
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)
昭和大学病院(東京都)
癌研究会有明病院(東京都)
虎の門病院(東京都)
神奈川県立がんセンター(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)
石川県立中央病院(石川県)
佐久総合病院(長野県)
静岡県立静岡がんセンター(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)
京都大学医学部附属病院(京都府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪医科大学(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
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)

Other administrative information
Date of disclosure of the study information
2007 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28224238
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 Main results already published
Date of protocol fixation
2007 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2014 Year 06 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
2007 Year 06 Month 08 Day
Last modified on
2017 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000885

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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