UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observation study of Trastuzumab for HER2 positive advanced or recurrent gastric cancer
Title of the study (Brief title)	Observation study of Trastuzumab for HER2 positive advanced or recurrent gastric cancer(KSCC1105)
Region	Japan

Condition
Condition	Advanced or recurrent gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Trastuzumab for the patients with HER2 positive advanced or recurrent gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Safety (rate and grade of adverse event) Rate and grade of Infusion reaction and treatment Rate and grade of cardiac events, and correlation with treatment and outcome Treatment line Treatment regimen Response Rate Progression Free Survival Time to Failure of Strategy Time to Treatment Failure Overall Survival
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Confirmed HER2 positive Treatment-Initiated after 10 March, 2011
Key exclusion criteria	Other than inclusion criteria
Target sample size	50

Research contact person
Name of lead principal investigator	Hideo Baba
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Gastroenterological Surgery
Address	1-1-1, Honjo, Kumamoto 860-8556, Japan
TEL	096-373-6211
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	KSCC secretariat
Organization	Clinical Research Support Center Kyushu
Division name	KSCC secretariat
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan
TEL	092-631-2920
Homepage URL	http://www.cres-kyushu.or.jp
Email	kscc2@cres-kyushu.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
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

健康保険人吉総合病院（熊本県）、中津市立中津市民病院（大分県）、宗像医師会病院（福岡県）、製鉄記念八幡病院（福岡県）、社会保険田川病院（福岡県）、大牟田市立病院（福岡県）、労働者健康福祉機構 岡山労災病院（岡山県）、伊万里有田共立病院（佐賀県）、国立病院機構 九州医療センター（福岡県）、佐世保市立総合病院（長崎県）、大分赤十字病院（大分県）、熊本大学（熊本県）、済生会熊本病院（熊本県）、松山赤十字病院（愛媛県）、広島赤十字・原爆病院（広島県）、長崎大学 腫瘍外科（長崎県）、長崎大学　移植・消化器外科（長崎県）、大分県立病院（大分県）、福岡歯科大学医科歯科総合病院（福岡県）、公立学校共済組合九州中央病院（福岡県）、神戸市立医療センター　中央市民病院（兵庫県）、久留米大学医療センター（福岡県）、国立病院機構大分医療センター（大分県）、田川市立病院（福岡県）、白十字会　佐世保中央病院（長崎県）、済生会福岡総合病院（福岡県）、九州大学（福岡県）、国立病院機構南九州病院（鹿児島県）、済生会川内病院（鹿児島県）、熊本赤十字病院（熊本県）、琉球大学（沖縄県）、久留米大学（福岡県）、福岡大学筑紫病院（福岡県）、高知医療センター（高知県）、国立病院機構別府医療センター（大分県）、宮崎県立日南病院（宮崎県）、三北播磨総合医療センター（兵庫県）、社会保険久留米第一病院（福岡県）、国立病院機構別府医療センター（大分県）、鹿児島大学（鹿児島県）、佐賀大学（佐賀県）、九州厚生年金病院（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 01 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	Published
URL releasing results
Results	ASCO-GI 2017 Trastuzumab beyond first progression in cases of HER2-positive advanced gastric or gastro-esophageal junction cancer: Initial results from KSCC1105, a trastuzumab observational cohort study. Akitaka Makiyama, Mototsugu Shimokawa, Tomomi Kashiwada, Ikuo Takahashi, Yasunori Emi, Tetsuya Kusumoto, Kazuharu Yamamoto, Hiroshi Ishikawa, Yuji Negoro, Eiji Oki, Hiroshi Saeki, Yoshihiro Kakeji, Hideo Baba,Yoshihiko Maehara, Kyushu Study Group of Clinical Cancer (KSCC)
Other related information	1) Patient information: height, body weight, sex, birth date, PS, patient ID 2) Disease information: diagnistic entity, stage, lesion site, treatment history 3) Laboratory test: liver function, kidney function, electrolyte, blood test, tumor marker 4) Treatment progress: adverse event(infusion reaction, cardiac disorder, etc), supportive treatment, treatment duration, discontinuation, etc 5) Outcome: deterioration, prognosis

Management information
Registered date	2012 Year 02 Month 08 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008467