UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005548 |
|---|---|
| Receipt number | R000006578 |
| Scientific Title | Neoadjuvant Chemotherapy for HER2-positive Stage IV advanced gastric cancer with S-1/Cisplatin/Trastuzumab |
| Date of disclosure of the study information | 2011/05/09 |
| Last modified on | 2011/05/09 10:18:36 |
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Basic information
Public title
Neoadjuvant Chemotherapy for HER2-positive Stage IV advanced gastric cancer with S-1/Cisplatin/Trastuzumab
Acronym
Neoadjuvant Chemotherapy for HER2-positive advanced gastric cancer with S-1/Cisplatin/Trastuzumab
Scientific Title
Neoadjuvant Chemotherapy for HER2-positive Stage IV advanced gastric cancer with S-1/Cisplatin/Trastuzumab
Scientific Title:Acronym
Neoadjuvant Chemotherapy for HER2-positive advanced gastric cancer with S-1/Cisplatin/Trastuzumab
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and antitumor effect of the S-1/Cisplatin/Trastuzumab
combination therapy on HER2-positive advanced Stage IV gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety of neoadjuvant chemotherapy
- Type and grade of adverse event
- Onset of adverse event
- Frequency of adverse events
- Duration of adverse event
- Rate of adverse events
Key secondary outcomes
Antitumor efficacy
Surgical resectability rate
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
Neoadjuvant Chemotherapy with S-1/Cisplatin/Trastuzumab
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, Cisplatin or Trastuzumab
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto, M.D., Ph.D. |
Organization
The University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Wada, M.D., Ph.D. |
Organization
The University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
03-3815-5411
Homepage URL
wadai-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department account fund
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 09 | 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
| 2011 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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 | 05 | Month | 02 | Day |
Last modified on
| 2011 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006578
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
