UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018403 |
|---|---|
| Receipt number | R000021306 |
| Scientific Title | A Phase III trial of inhibitory effect of metachronous gastric cancer by Helicobacter pylori eradication for patients after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2023/07/30 12:02:26 |
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Basic information
Public title
A Phase III trial of inhibitory effect of metachronous gastric cancer by Helicobacter pylori eradication for patients after endoscopic submucosal dissection
Acronym
RCT of helicobacter pylori eradication after gastric ESD
Scientific Title
A Phase III trial of inhibitory effect of metachronous gastric cancer by Helicobacter pylori eradication for patients after endoscopic submucosal dissection
Scientific Title:Acronym
RCT of helicobacter pylori eradication after gastric ESD
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to explore inhibitory effect of the incidence of metachronous gastric cancer by eradication of Helicobacter pylori for the patients with curative resection after endoscopic submucosal dissection (ESD). We conducted multicenter, randomized controlled study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of 5 -year cumulative metachronous gastric cancer
Key secondary outcomes
The proportion of 5 -year cumulative metachronous gastric cancer according to pepsinogen levels
The proportion of annual cumulative metachronous gastric cancer
Overall survival time
Disease free survival time
The proportion of the incidence of reflux esophagitis
The proportion of exacerbation of reflux esophagitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients in eradication group undergo eradication of Helicobacter pylori within 6 months after ESD.
Interventions/Control_2
Patients in non-eradication group are followed up without eradication of Helicobacter pylori.
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
| 60 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ESD specimen revealed tubular adenocarcinoma histologically and primary cancer
2) curative resection(absolute and expanded criteria)
3) both single and multiple lesions
4) lesions expected not to occur stricture due to ESD scar
5) Helicobacter pylori positive
6) no history of eradication of Helicobacter pylori
7) clinical N0 and M0
8) an age of 60 to 81 years
9) an Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0 or 1
10) no history of gastrectomy and esophagectomy
11) no prior chemotherapy within 5 years (in case of breast cancer, within 10 years)
12) laboratory data of total bilirubin is less than 2.5mg/dL, serum creatinine less than 2.0mg/dL
13) written informed consent
Key exclusion criteria
(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(2) Infectious disease with systemic therapy indicated.
(3) Body temperature of 38 or more degrees Celsius.
(4) pregnant or breast-feeding women
(5) Severe psychiatric disease.
(6) Continuous systemic steroid therapy.
(7) Unstable angina pectoris, or history of myocardial infarction within six months.
(8) Poorly controlled hypertension.
(9) Severe respiratory disease requiring continuous oxygen therapy.
(10)Penicillin allergy
(11) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ono |
Organization
Shizuoka Cancer Center
Division name
Endoscopy Division
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
h.ono@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ono |
Organization
Shizuoka Cancer Center
Division name
Endoscopy Division
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
h.ono@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
静岡県立静岡がんセンター（静岡県）
国立がん研究センター中央病院（東京都）
富山県立中央病院（富山県）
石川県立中央病院（石川県）
四国がんセンター（愛媛県）
京都大学（京都府）
国立がん研究センター東病院（千葉県）
佐野病院（兵庫県）
広島市民病院（広島県）
NTT関東病院（東京都）
がん研有明病院（東京都）
千葉県がんセンター（千葉県）
広島大学（広島県）
兵庫県立がんセンター（兵庫県）
栃木県立がんセンター（栃木県）
大阪府立成人病センター（大阪府）
高知医療センター（高知県）
岩手医大（岩手県）
神奈川県立がんセンター（神奈川県）
神戸大学（兵庫県）
大阪市立総合医療センター（大阪府）
慶応義塾大学（東京都）
京都府立医大（京都府）
京都第一赤十字病院（京都府）
弘前大学（青森県）
王子総合病院（北海道）
長崎大学（長崎県）
金沢大学（石川県）
市立四日市病院（三重県）
兵庫医大（兵庫県）
市立奈良病院（奈良県）
大阪市立大学（大阪府）
福島県立医大（福島県）
大阪府立急性期・総合医療センター（大阪府）
東京大学（東京都）
徳島大学（徳島県）
仙台オープン病院（宮城県）
大分大学（大分県）
埼玉医大国際医療センター（埼玉県）
順天堂大学（東京都）
武田病院（京都府）
東北大学（宮城県）
東京女子医大（東京都）
佐賀大学（佐賀県）
新潟県立中央病院（新潟県）
由利組合総合病院（秋田県）
戸畑共立病院（福岡県）
深谷赤十字病院（埼玉県）
聖マリアンナ医大（神奈川県）
市立秋田総合病院（秋田県）
秋田更生医療センター（秋田県）
JCHO大阪病院（大阪府）
帝京大学市原病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
| 2015 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021306
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| Registered date | File name |
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