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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005548
Receipt No. 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

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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
Email

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
Email wadai-sur@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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