UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Trastuzuman in combination with TS-1 and Cisplatin for patients with Human Epidermal Growth Facter Receptor type-2 (HER-2)-positive Advanced Gastric Cancer
Title of the study (Brief title)	"Trastuzumab, TS-1 plus Platinum ACtivity Evaluation" T-SPACE study
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study will evaluate the efficacy and safety of Trastuzumab in combination with TS-1 and cisplatin for patients with HER2 positive advanced gastric cancer. In addition, translational research to predict treatment efficacy is conducted.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression-free survival, Disease control rate, Overall survival, Time to Treatment Failure, Safety, Translational Research

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	Trastuzumab in combination with TS-1 and cisplatin
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) Patients with histologically proved adenocarcinoma of advanced gastric cancer and esophagogastric junction. 2) Patients without prior chemotherapy. i)In the patients with recurrence disease after curative tumor resection, adjuvant chemotherapy with fluoropyrimidine is permitted. ii)In the patients who received adjuvant chemotherapy with fluoropyrimidine, more than 6 months after completion of chemotherapy is necessary to enroll. 3) Patients who have HER2-positive cancer confirmed with IHC3+ or IHC2+/FISH >= 2.0. 4) ECOG performance status 0-2. 5) Patients with one or more measurable lesion as defined by the RECIST criteria. 6) Patients who can intake orally. 7) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 9.0 g/dL, platelet count >= 100,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 1.5 mg/dL), kidney function (serum creatinine <=1.2 mg/dL, creatinine clearance >= 60 ml/min). All laboratory data should be evaluated within 7 days before enrollment. 8) Patients with adequate cardiac function (LVEF [left ventricular ejection fraction] evaluated by echocardiography or MUGA scan >= 50%). 9) Patients with normal electrocardiography within 28 days before enrollment. 10) Expected survival >= 90 days. 11) Written informed consent obtained from patients.
Key exclusion criteria	1) Patients who received radiotherapy within 2 weeks before enrollment. 2) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 3) Patients with symptomatic brain metastases or carcinomatous meningitis. 4) Patients with other active malignancies. 5) Patients with active infections. 6) Patients with serious complications. 7) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. 8) Patients with a history of serious drug allergy. 9) Patients who receive continuous corticosteroid administration. 10) Patients who need to receive flucytosine. 11) Patients who need to receive continuous phenytoin or warfarin administration. 12) Patients with serious mental problem. 13) Pregnant or lactating female. 14) HBs antigen positive patients 15) Other patients evaluated to be inadequate to participate in this study by investigators.
Target sample size	55

Research contact person
Name of lead principal investigator	Yuji Miura
Organization	Toranomon Hospital
Division name	Department of Medical Oncology
Address	2-2-2 Toranomon, Minato-ku, Tokyo,JAPAN
TEL	03-3588-1111
Email

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Address	Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

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

龍ケ崎済生会病院（茨城県）、愛知県がんセンター中央病院（愛知県）、聖マリアンナ医科大学病院（神奈川県）、九州がんセンター（福岡県）、兵庫県立がんセンター（兵庫県）、千葉県がんセンター（千葉県）、大阪府立急性期・総合医療センター（大阪府）、虎の門病院（東京都）、恵佑会札幌病院（北海道）、徳島赤十字病院（徳島県）、大阪赤十字病院（大阪府）、済生会新潟第二病院（新潟県）、静岡県立総合病院（静岡県）、大阪市立総合医療センター（大阪府）、近畿大学医学部奈良病院（奈良県）、近畿大学医学部附属病院（大阪府）、自治医科大学附属病院（栃木県）、大分大学医学部附属病院（大分県）、高知医療センター（高知県）、香川大学医学部附属病院（香川県）、市立堺病院（大阪府）、近畿大学医学部堺病院（大阪府）、市立吹田市民病院（大阪府）、大阪府立成人病センター（大阪府）、愛媛県立中央病院（愛媛県）、大阪医科大学附属病院（大阪府）、九州医療センター（福岡県）、県立広島病院（広島県）、済生会宇都宮病院（栃木県）、札幌医科大学附属病院（北海道）、九州大学病院（福岡県）、高槻病院（大阪府）、富山大学附属病院（富山県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 02 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2015 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28497176
Results
Other related information

Management information
Registered date	2012 Year 07 Month 09 Day
Last modified on	2017 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009860