UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017182 |
|---|---|
| Receipt number | 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 | 2021/10/08 14:46:19 |
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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 | Hiromi |
| Middle name | |
| Last name | Kataoka |
Organization
Nagoya City University Hospital
Division name
Department of gastroenterology
Zip code
467-8601
Address
1 Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
hkataoka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Kataoka |
Organization
Nagoya City University Hospital, Department of gastroenterology
Division name
Nagoya City University Hospital, Department of gastroenterology
Zip code
467-8601
Address
1 Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
Homepage URL
hkataoka@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital, Department of gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Kidani 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
IRB of NCU
Address
1Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan.
Tel
052-851-5511
clinical_research@med.nagoya-cu.ac.jp
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
https://pubmed.ncbi.nlm.nih.gov/34550548/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34550548/
Number of participants that the trial has enrolled
25
Results
A total of 25 patients from six centers were enrolled. In the 25 patients evaluable for analysis, the 1-year survival rate was 70.8% [90% confidence interval (CI) = 55.5-86.1%], whereas the median OS, PFS, and ORR were 17.8 months, 7.6 months, and 75.0%, respectively. Major grade 3/4 adverse events included anorexia (20%), anemia (16%), peripheral sensory neuropathy (16%), and diarrhea (15%).
SOX100 combined with trastuzumab was effective with a favorable safety profile in patients with HER2-positive AGC.
Results date posted
| 2021 | Year | 10 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 09 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019936
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