UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014401 |
|---|---|
| Receipt number | R000011295 |
| Scientific Title | A study of Sentinel Node Navigation Surgery for Early Gastric Cancer |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2019/07/26 10:28:42 |
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Basic information
Public title
A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Acronym
A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Scientific Title
A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Scientific Title:Acronym
A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Region
| Japan |
Condition
Condition
Clinically T1N0 gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the availability and safety of the individuarized gastrectomy based on sentinel node concept for the early gastric cancer
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Postoperative 5-year recurrence free survival(RFS) ratio
Key secondary outcomes
postoperative 3-year RFS rate, postoperative 3/5-year overall survival, sentinel node detection rate, distribution, sensitivity, accuracy for lymph node metastases, quality of life after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Minimized gastrectomy and sentinel basin resection group :
for the patients whose sentinel nodes were negative by intraoperative pathological diagnosis and spread within the confines of the resection range of minimized surgery.
Interventions/Control_2
Conventional gastrectomy and sentinel basin resection group :
for the patients whose sentinel nodes were negative by intraoperative pathological diagnosis and spread beyond the confines of the resection range of minimized surgery.
Interventions/Control_3
Conventional gastrectomy group :
for the patients whose sentinel nodes were positive by intraoperative pathological diagnosis.
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) Clinically diagnosed T1N0 early gastric cancer
2) Single lesion
3) Less than 40mm in size
4) Provided written informed concent
5) Histopathological type does not matter
Key exclusion criteria
1) Pregnancy, severe drug allergy, asthoma.
2) Multiple lesion
3) With prior treatment to same lesion
4) Synchronous or metachronous (within 5 years) malignancies.
5) Judged as irrelevant object for this study
6) Refusal of the trial entry
7) Remnant gastric cancer
8) Absolute indication for endoscopic treatments
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
hkawakubo@z3.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
鹿児島大学医学部・歯学部附属病院（鹿児島県）、国立大学法人三重大学医学部附属病院（三重県）、岩手医科大学附属病院（岩手県）、東京医科大学病院（東京都）、石川県立中央病院（石川県）、千葉大学医学部附属病院（千葉県）、防衛医科大学校病院（埼玉県）、公立大学法人福島県立医科大学附属病院（福島県）、金沢大学附属病院（石川県）、東海大学医学部附属病院（神奈川県）、埼玉メディカルセンター（埼玉県）、東京慈恵会医科大学附属病（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、金沢医科大学（石川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011295
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