UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013860 |
|---|---|
| Receipt number | R000016169 |
| Scientific Title | A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2020/05/07 08:19:21 |
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Basic information
Public title
A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer
Acronym
RDG phase II
Scientific Title
A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer
Scientific Title:Acronym
RDG phase II
Region
| Japan |
Condition
Condition
Patients with Stage IA and IB gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety of robot assisted distal and total gastrectomy with lymph node dissection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)
Key secondary outcomes
Oveall survival
Relapse free survival
Completion rate of robot assised surgery
The incidence of adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot assisted 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) Biopsy specimen from the primary lesion shows adenocarcinoma
2) Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
3) Endoscopic submucosal dissection is not indicated
4) Tumor was located within lower two thirds of stomach
5) Not having duodenal invasion
6) Eeatern clinical oncology group performans status is 0 or 1
7) Body mass index is lower than 30
8) No previous laparotomy
9) No previous chemotherapy or radiation including those for other cancers
10) Fulfil all following conditions
WBC > 3,000/mm3
Plt > 100,000/mm3
AST < 100 IU/L
ALT < 100IU/L
T.Bil < 2.0 g/dl
Cre < 1.5mg/dl
Key exclusion criteria
1) Having other active cancers
2) Possibly pregnant, or breast feeding woman
3) with psychiatric disorder
4) Receiving steroids
5) With Acute myocardial infaction in 6 months or with unstable ungina
6) With uncontrolled hypertention
7) With uncontrolled diabetes mellitus
8) With pulmonary disease and require continuous oxygen therapy
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kawashima |
Organization
Saitama Cancer Center
Division name
Division of Gastric Surgery
Zip code
362-0806
Address
780, Komuro, Ina-city, Kita-Adachi-gun, Saitama, Japan
TEL
048-722-1111
ykawashima@cancer-c.pref.saitama.jp
Public contact
Name of contact person
| 1st name | Ehara |
| Middle name | |
| Last name | Kazuhisa |
Organization
Saitama Cancer Center
Division name
Division of Gastric Surgery
Zip code
362-0806
Address
780, Komuro, Ina-city, Kita-Adachi-gun, Saitama, Japan
TEL
048-722-1111
Homepage URL
http://www.saitama-cc.jp/userinfo/clinical-trial.html
kehara@cancer-c.pref.saitama.jp
Sponsor or person
Institute
Saitama Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Cancer Center
Address
780, Komuro, Ina-city, Kita-Adachi-gun, Saitama, Japan
Tel
0487221111
sccctmo01@cancer-c.pref.saitama.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
埼玉県立がんセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | 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
| 2014 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 20 | 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 | 05 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016169
| Research Plan | |
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| Registered date | File name |
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