UMIN-CTR Clinical Trial

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
Email	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
Email	hkataoka@med.nagoya-cu.ac.jp

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

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019936