UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008220 |
|---|---|
| Receipt number | R000009687 |
| Scientific Title | A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer. |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2017/10/27 15:47:36 |
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Basic information
Public title
A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.
Acronym
STAR study
Scientific Title
A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.
Scientific Title:Acronym
STAR study
Region
| Japan |
Condition
Condition
advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility, safety and efficacy of TS-1 + Trastuzumab for HER2-positive advanced gastric cancer .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
treatment completion ratio
Key secondary outcomes
respons rete, progression-free survival, overall survival, time to treatment failure, 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
Drug:TS-1 and Trastuzumab
TS-1:80mg/m2 on Day 1-28
Trastuzumab:6mg/kg on Day 1 and Day 22 (first time: 8mg/kg)
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) Histopathological confirmation of Adenocarcinoma
2) Unresectable or recurrent gastric cancer
3) Previously-treated patient
4) HER2-positive tumor
5) Age 20
6) ECOG performance status of 0 to 2
7) Adequate organ function as follows:
1.Neu : >= 1,500 /mm3
2.Platelet : >= 100,000 /mm3
3.hemoglobin : >= 9.0 g/dL
4.AST, ALT : < 100 IU/L
5.St.bil : < 1.5 mg/dL
6.Serum creati : <= 1.2 mg/dL
7.Ccr : >= 60 ml/min
8) Ejection fraction more than 50% by ultrasound or MUGA
9) Normal electrocardiogram which was performed within 21 days
10) Sufficient oral intake
11) Expected more than 3 months survival
12) Written informed consent
Key exclusion criteria
1) Prior chemotherapy of TS-1
2) With severe allergy to TS-1 and Trastuzumab
3) Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant.
4) Active infection and inflammation.
5) History of cardiac disease
6) Patients with Severe complications
7) Patients with resting dyspnea
8) Patients with gastrointestinal ulceration and bleed
9) Patients with diarrhea (4 or more times per day or watery diarrhea).
10) Massive pleural or abdominal effusion
11) Patients with metastasis to CNS
12) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
13) Patients under treatment with flucytosine, phenytoin or warfarin potassium
14) Patients who are received systemic administration of corticosteroid.
15) Other patients who are unfit for the study as determined by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naotoshi Sugimoto |
Organization
Osaka medical center for cancer and cardiovascular diseases
Division name
Department of Clinical Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
sugimoyo-na2@mcpref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotoshi Sugimoto |
Organization
Osaka medical center for cancer and cardiovascular diseases
Division name
Department of Clinical Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
sugimoyo-na2@mcpref.osaka.jp
Sponsor or person
Institute
Osaka medical center for cancer and cardiovascular diseases
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
| 2012 | Year | 06 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009687
