UMIN-CTR Clinical Trial

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

Advanced or recurrent gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

02

Month

08

Day

URL releasing protocol

Publication of results

Published

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

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 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

Registered date

2012

Year

02

Month

08

Day

Last modified on

2017

Year

04

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008467