UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000737 |
|---|---|
| Receipt number | 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 15:43:10 |
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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 ≤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
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/
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000885
