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Recruitment status Completed
Unique ID issued by UMIN UMIN000007368
Receipt No. R000008675
Scientific Title Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Date of disclosure of the study information 2012/02/23
Last modified on 2018/03/08

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Basic information
Public title Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Acronym JACCRO GC-06
Scientific Title Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Scientific Title:Acronym JACCRO GC-06

Condition HER2-positive advanced gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Narrative objectives1 Evaluation ofr the efficacy and safety of S-1 plus trastuzumab for elderly (more than 65 years old) HER2-positive advanced gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Primary outcomes Response rate (RR)
Key secondary outcomes Overall survival(OS)
Progression free survaval(PFS)
Time to treatment faulure(TTF)

Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Dynamic allocation
Institution consideration

No. of arms 1
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 Drug:TS-1 and Trastuzumab
TS-1:80mg/m2/dat on Day 1-28
Trastuzumab:6mg/kg/body on Day 1 and Day 22 (first time: 8mg/kg/body)

Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction.
2) Patients who have measurable region defined by RECIST version 1.1.
3) Patients who have HER2-positive cancer confirmed with IHC and /or FISH (IHC 3+ or IHC2+ and FISH positive)
4) More than 65 years old.
5) Performance status (ECOG scale) 0, 1 or 2.
6) No prior chemotherapy or radiotherapy for gastric cancer.
7) Adequate baseline organ and marrow function as defined below:
1. Leukocyte : 3,500-12,000/mm3
2. Absolute neutrophil count : >= 2,000/mm3
3. Platelets : >= 100,000/mm3
4. Hemoglobin : >=9.0g/dL
5. AST : < 100IU/L
6. ALT : < 100IU/L
7. Total bilirubin : < 1.5mg/dL
8. Serum creatinine : <= 1.2mg/dL
9. Creatinine clearance : >= 50ml/min
8) Patients with left ventricular ejection fraction of at leaset 50% on MUGA scan or echocardiography done within 21days before enrollment.
9) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment
10) Patients able to take orally
11)Life expectancy of greater than 3 months
12) Patients should sign a written informed consent.
Key exclusion criteria 1) Scond primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence)
2) Severe ascites and / or pleural effusion
3) Patients with brain metastasis
4) Patients with fresh bleeding from gastric cancer and / or the digestive tract
5) Patients with active infection (> 38C)
6) Patients have active hepatitis type B
7) Patients with a previous history of congestive heart failure
8) Unstable angina requiring medication
9) Patients with a previous history of transmural infarct
10) Uncontrolled hypertension
11) Severe heart valve diseases
12) Hi-risk uncontrolled arrhythmias
13) Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus
14) Patients with resting dyspnea
15) Patients with diarrhea (4 or more times per day or watery diarrhea) 16) Patients who are contraindicated to TS-1 and Trastuzumab
17) Hypersensitivity to have a history TS-1 and / or Trastuzumab
18) Patients who are received systemic continuous admnistration of flucytosine.
19) Patients who are recieving systemic continuous administration of phenytoin or warfarin
20) Patients who are received systemic administration of corticosteroid for a long time or with high doses
21) Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. Men who want their partners to become pregnant.
22) Any patinets judged by the investigator to be unfit to perticipate in the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Takiuchi
Organization Osaka Medical College
Division name Cancer Chemotherapy Center
Zip code
Address 2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181
TEL 03-3293-1711

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fujii
Organization Japan Clinical Cancer Research Organization
Division name Secretariat
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo
TEL 03-5579-9882
Homepage URL

Institute Japna Clinical Cancer Research Organizetion

Funding Source
Organization Taiho Pharmaceutical Co. Ltd.
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 大阪医科大学附属病院(大阪府)ほか、JACCRO参加施設

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

URL related to results and publications
Number of participants that the trial has enrolled
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

Recruitment status Completed
Date of protocol fixation
2011 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
2016 Year 02 Month 28 Day
Date trial data considered complete
2016 Year 09 Month 01 Day
Date analysis concluded
2016 Year 11 Month 01 Day

Other related information

Management information
Registered date
2012 Year 02 Month 23 Day
Last modified on
2018 Year 03 Month 08 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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