UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021209 |
|---|---|
| Receipt number | R000024455 |
| Scientific Title | A phase II trial of tri-week cycle TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/02/25 10:07:25 |
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Basic information
Public title
A phase II trial of tri-week cycle TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced or recurrent gastric cancer
Acronym
A phase II trial of TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced gastric cancer
Scientific Title
A phase II trial of tri-week cycle TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced or recurrent gastric cancer
Scientific Title:Acronym
A phase II trial of TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of TS-1+L-OHP+Trastuzumab combination therapy for advanced gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
incidence and extent of adverse events, progression-free survival, overall survival, time to treatment failure
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 or 100mg/m2 or 120mg/m2 twice a day on days 1-14 in 3 weeks
L-OHP:130mg/m2 intravenous injection on day1
Trastuzumab:8mg/kg(1st cycle) or 6mg/kg(after 2nd cycle) intravenous injection 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)Histopathologically proven advanced / recurrence gastric adenocarcinoma
2)Have measurable lesions by RECIST version 1.1
3)Positive for HER2 (IHC 3+ or IHC2+/FISH+)
4)Age 20-75
5)ECOG PS 0 or 1
6)No previous therapy for gastric cancer except for adjuvant chemotherapy which was finished more than 6 months
7)Neither ascites nor pleural effusion
8)No symptomatic cerebral lesions
9)Adequate organ functions (according to the hematologic test which was taken within 2 weeks before registration)
WBC => 3,500/mm3 and =< 12,000/mm3
Neutrophil => 2,000/mm3
Platelet => 100,000/mm3
Hemoglobin => 9.0g/dL
AST and ALT =< 100 IU/L
Total bilirubin =< 1.5 mg/dL
Creatinine =< 1.2mg/dL
Creatinine clearance => 60ml/min
10)LVEF (Left Ventricular Ejection Fraction) >50% within 3 weeks before registration
11)No abnormal findings in ECG within 3 weeks before registration
12)Possible for oral ingestion
13)With an expectation of survival more than 3 months
14)With written Informed Consent
Key exclusion criteria
1) Who cannot administrate TS-1, L-OHP and Trastuzumab
2)Pregnant and / or nursing women or men who wish to have children in future
3)With active infectious disease
4)Positive for HBs antigen
5)Have a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease and uncontrollable hypertension
6)With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure and uncontrollable diabetes mellitus
7)With dyspnea at rest
8)With active bleeding from gastric cancer or ulcer
9)With severe diarrhea (over 4 times a day or watery diarrhea)
10)With active double cancers excluding carcinoma in situ and / or prior curative cancer with relapse free for more than 5 years
11)Under medication of flucytosine or phenytoin,or warfarin
13)Under continuous medication of steroids
14)Judged to be unfit for this study by investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsui Takashi |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Department of Surgery
Zip code
Address
2-1-50 Minami-Koshigaya, Koshigaya city, Saitama 343-8555, JAPAN
TEL
048-965-1111
mitsuitakashi3@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsui Takashi |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Department of Surgery
Zip code
Address
2-1-50 Minami-Koshigaya, Koshigaya city, Saitama 343-8555, JAPAN
TEL
048-965-1111
Homepage URL
mitsuitakashi3@gmail.com
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 03 | Month | 01 | 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
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2018 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024455
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| Registered date | File name |
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| Registered date | File name |
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