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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017182
Receipt No. R000019936
Scientific Title Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer
Date of disclosure of the study information 2015/04/20
Last modified on 2020/04/03

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Basic information
Public title Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer
Acronym Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer
Scientific Title Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer
Scientific Title:Acronym Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer
Region
Japan

Condition
Condition HER2 positive gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 One year survival rate
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes One year survival rate
Key secondary outcomes OS, PFS, RR, molecular marker expression analysis,

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 Chemotherapy for gastric cancer
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.case which was diagnosed as gastric cacner by histopathologically.
2. unresectable gastric cancer
3. HER2 positive (IHC 3+ or IHC 2+ and FISH positive)
4. age 20-80 Y
5. ECOG PS:0-2
6. case which has lesions to be evaluated
7. patient who is possible of ingestion
8. initial treatment case (patient who had adjuvant chemotherapy by TS-1 more than 24 weeks ago)
9. patient who is expected to be survival more than 3 months
10. LVEF>50% by UCG
11.
WBC:3,000 / mm3-12,000 / mm3
Neutro:>1,500/mm3
Plt:>100,000/mm3
Hb:>9.0 g/dl
AST(GOT),ALT(GPT):<100 IU / l
T-Bil:<2.0mg / dl
C.Cr:>60ml / min (Cockcroft- Gault)
12. patient who was taken IC by document
Key exclusion criteria 1.patient who has drug allergy as past history
2. case of administration contraindication
3. patient who needs flucytosine, phenytoin, and Warfarin
4. patient who has active infectious disease with fever over 38 degree
5. patient who has severe complication (intestinal palsy, ileus, interstitial pneumonia, DM, renal failure, liver failure under bad control)
6. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a
valvular disease of the heart)
7. patient who has metastatic brain tumor with symptoms
8. watery diarrhea
9. severe ascites and/or pleural effusion
10. patient who has active double cancer
11. patient who want to be pregnant and /or pregnant woman
12. man who want to have a child
13. patient who was not judged to be suitable for this clinical trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Kataoka
Organization Nagoya City University Hospital
Division name Department of gastroenterology
Zip code
Address 1 Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-851-5511
Email hkataoka@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Kataoka
Organization Nagoya City University Hospital, Department of gastroenterology
Division name Nagoya City University Hospital, Department of gastroenterology
Zip code
Address 1 Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-851-5511
Homepage URL
Email hkataoka@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Hospital, Department of gastroenterology
Institute
Department

Funding Source
Organization Kitani memorial trust
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan Red Cross Nagoya Daini Hospital, Nagoya City East Medical Center, Nagoya City West Medical Center, Toyokawa Municipal Hospital, Gifu Prefectural Tajimi Hospital, Chukyo Hospital, Kasugai Municipal Hospital, Gamagoori Municipal Hospital, Aichi Medical University Hospital
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 20 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
2015 Year 03 Month 18 Day
Date of IRB
2015 Year 03 Month 09 Day
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 20 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019936

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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