UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006603 |
|---|---|
| Receipt number | R000006729 |
| Scientific Title | A phase II study of S-1/Cisplatin/Trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced and/or recurrent gastric cancer |
| Date of disclosure of the study information | 2011/10/24 |
| Last modified on | 2018/09/12 18:47:02 |
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Basic information
Public title
A phase II study of S-1/Cisplatin/Trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced and/or recurrent gastric cancer
Acronym
HOG-GC 01
Scientific Title
A phase II study of S-1/Cisplatin/Trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced and/or recurrent gastric cancer
Scientific Title:Acronym
HOG-GC 01
Region
| Japan |
Condition
Condition
advanced and/or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and tolerability of trasuzumab added to S-1+cisplatin in HER2-positive advanced and/or recurrent gastric cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
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 is orally administered for 3 weeks followed by 2 weeks rest according to body surface area (80mg/m2/day). CDDP is administered intravenously in each dosage of level(60mg/m2/day) at day 8.
Trastuzumab is administered intravenously 6mg/kg at day 8 and 4mg/kg at day 21.
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) Pathological proven adenocarcinoma of inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach
2) HER2-positive tumors
3) Age 20-75 years
4) ECOG performance status<=2
5) Measurable disease or non-measurable but assessable disease
6)No prior chemotherapy except for adjuvant chemotherapy with S-1
7)Sufficient oral intake
8)Adequate organ function
9) Ejection fraction more than 50% by
ultrasound or MUGA
10) Expected more than 3 months survival
11) With written informed consent
Key exclusion criteria
1) history of a previous drug allergy
2) pregnant or nursing patient or with intent to bear baby
3)R1 gastrectomy
4)need continuing use of flucytosine, phenytoin, warfarin potassium
5)Active infection or other inflammatory disease
6)with severe allergy to Trastuzumab, S-1 and cisplatin
7)History of cardiac disease
8)patients with serious concomitant diseas
9)with diarrhea
10)with ascites or pleural effusion
11)with multiple bone metastasis
12)peripheral sensory neuropathy
13)with brain metastasis
14)received operation within 28 days
15)simultaneous or metachronous double cancers
16)with clinically important mental disorder need to treat
17)cannot stopped steroids or immunosuppressing drug
18)Infection with hepatitis B
19)Inappropriate for the trial at the physician's assessment
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ninomiya Motoki |
Organization
Hiroshima City Hospital
Division name
Surgery
Zip code
Address
7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL
082-221-2291
motoki-n@city-hosp.naka.hiroshima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanabe Kazuaki |
Organization
Hiroshima University
Division name
Gastroenterological Surgery
Zip code
Address
1-2-3, Kasumi, MInami-ku
TEL
082-257-5555
Homepage URL
ktanabe2@hiroshima-u.ac.jp
Sponsor or person
Institute
HOG-GC (Hiroshima oncology group of gastric cancer)
Institute
Department
Personal name
Funding Source
Organization
HOG-GC (Hiroshima oncology group of gastric cancer)
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
| 2011 | Year | 10 | Month | 24 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006729
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