UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006647 |
|---|---|
| Receipt number | R000007862 |
| Scientific Title | A feasibility study of S-1/CDDP after gastrectomy for patients with SS/SE gastric cancer |
| Date of disclosure of the study information | 2011/11/04 |
| Last modified on | 2011/11/01 19:44:50 |
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Basic information
Public title
A feasibility study of S-1/CDDP after gastrectomy for patients with SS/SE gastric cancer
Acronym
CCOG1106
Scientific Title
A feasibility study of S-1/CDDP after gastrectomy for patients with SS/SE gastric cancer
Scientific Title:Acronym
CCOG1106
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the feasibility of postoperative S-1/CDDP in patients with stage III/IV gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
completion rates of 4 courses treatment of S-1/CDDP
Key secondary outcomes
relative performance of S-1/CDDP, overall survival, progression free survival. adverce 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
| Medicine |
Interventions/Control_1
S-1/CDDP
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
Stage III/IV
postoperative therapy
Key exclusion criteria
HER2 positive
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya university
Division name
Gastroenterological surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoyam, Aichi, Japan
TEL
052-744-2250
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norifumi Ohashi |
Organization
Nagoya university
Division name
Gastroenterological surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoyam, Aichi, Japan
TEL
052-744-2250
Homepage URL
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Chubu Clinical Oncology Group
Organization
Division
Category of Funding Organization
Other
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
中部臨床腫瘍研究機構
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 01 | Day |
Last modified on
| 2011 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007862
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
