UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.
Title of the study (Brief title)	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	Naotoshi Sugimoto
Organization	Osaka medical center for cancer and cardiovascular diseases
Division name	Department of Clinical Oncology
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL	06-6972-1181
Email	sugimoyo-na2@mcpref.osaka.jp

Public contact
Name of contact person	Naotoshi Sugimoto
Organization	Osaka medical center for cancer and cardiovascular diseases
Division name	Department of Clinical Oncology
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL	06-6972-1181
Homepage URL
Email	sugimoyo-na2@mcpref.osaka.jp

Sponsor
Institute	Osaka medical center for cancer and cardiovascular diseases
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 01 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009687