UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017602 |
|---|---|
| Receipt number | R000019954 |
| Scientific Title | A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer |
| Date of disclosure of the study information | 2015/05/18 |
| Last modified on | 2019/05/20 12:48:43 |
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Basic information
Public title
A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer
Acronym
HIGHSOX study
Scientific Title
A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer
Scientific Title:Acronym
HIGHSOX study
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of S-1 plus Oxaliplatin with Trastuzumab for advanced gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Progression free survival,Overall survival, Safety
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
S-1: 80mg/m2 twice a day on days1-14 in 3 weeks
Trastuzumab:8mg/kg(1st cycle)/6mg/kg(2nd cycle-) div. on day1
Oxaliplatin: 130mg/m2 div. on day1
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)histrologically proven advanced/recurrence adenocarcinoma
2)no prior therapy for gastric cancer except for adjuvant chemotherapy of S-1 which was finished more than 6 months ago
3)with measurable lesions by RECIST version 1.1
4)HER2 positve(IHC 3+ or IHC2+ and ISH+)
5)Age 20-75
6)ECOG PS 0 or 1
7)no symptomatic cerebral lesions
8)adequate organ functions(according to the labo-data which was taken within 2weeks before registration)
1. WBC =>3,000/mm3
2.neutrophil=>1,500/mm3
3.platelet=>100,000/mm3
4.AST=<100 IU/l
5.ALT=<100 IU/l
6.Total bililubin =<1.5 mg/dl
7. Creatinine=<1.2mg/dl
8. Creatinine clearance=>60ml/min
9) LVEF(Left Ventricular Ejection Fraction) >50% within 4weeks before registration
10) no abnormal findings in ECG within 4weeks before registration
11) possible for oral intake
12) with an expected survival longer than 3 months
13) with written Informed Consent
Key exclusion criteria
1) could not administrate S-1,Oxaliplatin,and Trastuzumab
2)pregnant and/or nursing women or men who wish to have children in future
3)with actuve infectious disease
4)HBs antigen positive
5)with a histroy or current symptoms of heart failure, uncontrollable arrhythmia,angina pectoris,valvular disease,and uncontrollable hypertension
6)with interstitial pneumonia, pulmonary fibrosis, heart hailure, renal failure, hepatic failure, uncontrollable diabetes mellitus
7)with dyspnea at rest
8)with active bleeding from gastric cancer/ulcer
9)with severe diarrhea(over 4 times a day or watery diarrhea)
10)with severe sensory neuropathy
11)with active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years
12)under meditation of flucytosine, phenytoin,or warfarin
13) under continuous meditation of steroids
14)judged to be unfit to participate in this study by investigater
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Takahari |
Organization
Cancer Institute Hospital
Japanese Foundation For Cancer Research
Division name
gastroenterology
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
TEL
03-3520-0111
daisuke.takahari@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Dasiuke |
| Middle name | |
| Last name | Takahari |
Organization
Cancer Institute Hospital
Division name
gastroenterology
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
TEL
03-3520-0111
Homepage URL
daisuke.takahari@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Japanese Foundation For Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital
Japanese Foundation For Cancer Research
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japanese Foundation for Multidisciplinary Treatment of Cancer
IRB Contact (For public release)
Organization
Cancer Institute Hospital Japanese Foundation For Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
Tel
03-3520-0111
med.shinsa@jfcr.or.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
大阪医科大学(大阪府）、千葉県がんセンター（千葉県）、愛知県がんセンター中央病院（愛知県）、四国がんセンター（愛媛県）国立がん研究センター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）静岡県立総合病院（静岡県）、聖マリアンナ医科大学（神奈川県),茨城県立中央病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s10120-019-00973-5
Number of participants that the trial has enrolled
75
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 17 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 23 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019954
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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