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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007246
Receipt No. R000008467
Scientific Title Observation study of Trastuzumab for HER2 positive advanced or recurrent gastric cancer
Date of disclosure of the study information 2012/02/08
Last modified on 2017/04/30

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Basic information
Public title Observation study of Trastuzumab for HER2 positive advanced or recurrent gastric cancer
Acronym Observation study of Trastuzumab for HER2 positive advanced or recurrent gastric cancer(KSCC1105)
Scientific Title Observation study of Trastuzumab for HER2 positive advanced or recurrent gastric cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideo Baba
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name KSCC secretariat
Organization Clinical Research Support Center Kyushu
Division name KSCC secretariat
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
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

Other
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

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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