UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Title of the study (Brief title)	JACCRO GC-06
Region	Japan

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

Objectives
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

Assessment
Primary outcomes	Response rate (RR)
Key secondary outcomes	Overall survival(OS) Progression free survaval(PFS) Time to treatment faulure(TTF) 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/dat on Day 1-28 Trastuzumab:6mg/kg/body on Day 1 and Day 22 (first time: 8mg/kg/body)
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	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	Hiroya Takiuchi
Organization	Osaka Medical College
Division name	Cancer Chemotherapy Center
Address	2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181
TEL	03-3293-1711
Email	masashi.fujii@gioncology.jp

Public contact
Name of contact person	Masashi Fujii
Organization	Japan Clinical Cancer Research Organization
Division name	Secretariat
Address	1-14-5 Ginza, Chuo-ku, Tokyo
TEL	03-5579-9882
Homepage URL
Email	gc06.dc@jaccro.or.jp

Sponsor
Institute	Japna Clinical Cancer Research Organizetion
Institute
Department

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

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	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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008675