UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006115 |
|---|---|
| Receipt number | R000007232 |
| Scientific Title | A phase2 study of trastumab and TS-1 for HER2-positive advanced gastric cancer |
| Date of disclosure of the study information | 2011/08/04 |
| Last modified on | 2014/02/05 11:13:08 |
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Basic information
Public title
A phase2 study of trastumab and TS-1 for HER2-positive advanced gastric cancer
Acronym
trastumab and TS-1 for HER2-positive advanced gastric cancer
Scientific Title
A phase2 study of trastumab and TS-1 for HER2-positive advanced gastric cancer
Scientific Title:Acronym
trastumab and TS-1 for HER2-positive advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is elucidate the anticancer efficacy and feasibility of TS-1 and trastuzumab combination therapy for HER2-positive advanced gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival
Response rate
Adverse event
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
TS-1 orally in 2 divided doses for 2weeks on and 1week rest
trastuzumab intravenously on day1 of every 3weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
2) Positive HER2 status
3) Lesions confirmed on imaging within 28 days before registration
4) No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
5) ECOG Performance Status of 0 to 2
6) Adequate Major organ functions within 14 days before registration
7) Life expectancy of at least 3 months after registration
8) Written informed consent
9) Age of 20 to 74 years with either gender
Key exclusion criteria
1) Past history of drug allergy
2) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
3) R1 operation(histlogically positive PM, OM, LM, VM )
4) Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
5) Patient with clinically obvious
infecton
6) Past history of drug allergy of
S-1, CDDP and Trastuzumab
7) Heart disease that is serious or requires hospitalization, or history of such disease within past year
8) Chronic diarrhea (watery stool or 4 times or more/day)
9) Massive ascites
10) Multiple bone metastasis
11) Clinical suspicion or previous history of metastasis to brain or meninges
12) Operation within 28day
13) More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
14,15) Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage
16) requiring steroid drug
17) Active hepatitis type HBs positive
18) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hirahara, M.D., Ph.D. |
Organization
Shimane University Hospital
Division name
Digestive and General Surgery
Zip code
Address
89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
TEL
0853-20-2232
norinori@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hirahara, M.D., Ph.D. |
Organization
Shimane University Hospital
Division name
Digestive and General Surgery
Zip code
Address
89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
TEL
0853-20-2232
Homepage URL
norinori@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
島根大学病院（島根県）、島根県立中央病院（島根県）、雲南市立病院（島根県）、出雲市立総合医療センター（島根県）、浜田医療センター（島根県）、松江赤十字病院（島根県）、松江生協病院（外科）、益田医師会病院（島根県）、町立奥出雲病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 04 | 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
| 2011 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 08 | Month | 04 | Day |
Last modified on
| 2014 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007232
