UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007436 |
|---|---|
| Receipt number | R000008762 |
| Scientific Title | Phase I/II multicenter clinical trial of S-1/CDDP/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer |
| Date of disclosure of the study information | 2012/03/03 |
| Last modified on | 2012/03/03 04:33:15 |
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Basic information
Public title
Phase I/II multicenter clinical trial of S-1/CDDP/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer
Acronym
Phase I/II clinical trial of S-1/CDDP/Trastuzumab therapy for HER2-positive advanced gastric cancer
Scientific Title
Phase I/II multicenter clinical trial of S-1/CDDP/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer
Scientific Title:Acronym
Phase I/II clinical trial of S-1/CDDP/Trastuzumab therapy for HER2-positive advanced gastric cancer
Region
| Japan |
Condition
Condition
HER2-positive Stage IV advanced gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of S-1/CDDP/Trastuzumab combination chemotherapy on HER2-positive Stage IV advanced gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Safety
- Type and grade of adverse event
- Frequency of adverse events
Efficacy
- Time to treatment failure(TTF)
- Progression free survival(PFS),
- Overall survival(OS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1/CDDP/Trasutzumab combination chemotherapy
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. Gastric cancer confirmed by histology
2. HER2 positive confirmed by histology
(IHC(immunohistochemistry) 3+, or IHC 2+ and FISH (fluorescence in situ hybridization) positive))
3. Stage IV advanced gastric cancer
4. Tumor lesion able to be measured
5. Performance Status (ECOG) 0-1
Key exclusion criteria
1. Malignant tumor of other organs
2. Severe medical condition
3. Active bleeding from gastrointestinal tract
4. Poor oral intake
5. Contraindication for S-1, CDDP or Trastuzumab
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
The University of Tokyo
Division name
Dept. of Gastrointestinal Surgery
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Wada |
Organization
The University of Tokyo
Division name
Dept. of Gastrointestinal Surgery
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
wadai-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
Dept. of Gastrointestinal Surgery, The University of Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 03 | Month | 03 | Day |
Last modified on
| 2012 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008762
