UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018350 |
|---|---|
| Receipt number | R000021244 |
| Scientific Title | The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer |
| Date of disclosure of the study information | 2015/07/19 |
| Last modified on | 2020/01/21 20:14:44 |
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Basic information
Public title
The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer
Acronym
The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer
Scientific Title
The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer
Scientific Title:Acronym
The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Inspection of efficacy and safety of laparoscopic gastrectomy for advanced gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Achievemnt rate
Background
Procedure
Operation time
Blood loss
Intraoperative complication
Postoperative complication
Postoperative chemotherapy
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
Surgery
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 gastric carcinoma
2) MP,SS or deeper lesion without involvement of other organs, N0-2 excluding bulky N2 and M0 according to the Japanese classification system
3) tumor located in the upper, body and antrum of the stomach and indication for total or distal gastrectomy
4)No invasion to duodenum
5) Aged 20 to 80 year
6) PS (ECOG)0 or 1
7) Body mass index < 30
8) no history of gastrointestinal surgery
9) no history of chemotherapy or radiotherapy
10) Sufficient organ functions
11) provided written informed consent
Key exclusion criteria
1)Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
2)Women during pregnancy or breast-feeding.
3)Severe mental disease.
4) Continuous systemic steroid therapy.
5)History of myocardial infarction or unstable angina pectoris within six months.
6)Uncontrollable hypertension.
7)Uncontrollable diabetes millutus or administration of insulin.
8)Severe respiratory disease requiring continuous oxygen therapy.
9)Severe adhesion.
10)Severe circulative disfunction.
11)No resection.
12)The person in charge judges as an inappropriate case.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akinibu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University
Division name
Gastroenterological Surgery I
Zip code
060-8638
Address
N15, W7, kita-ku, Sapporo, Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yoshida |
Organization
Hokkaido University
Division name
Gastroenterological Surgery I
Zip code
060-8638
Address
N15, W7, kita-ku, Sapporo, Japan
TEL
011-706-5927
Homepage URL
ta73825@dg7.so-net.ne.jp
Sponsor or person
Institute
Gastroenterological Surgery I, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hokkaido University
Address
N15, W7, kita-ku, Sapporo, Japan
Tel
011-706-7636
none
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 19 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021244
