UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024492
Receipt No. R000027921
Scientific Title Multicenter observational study on HER2 Status in HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab KSCC1604 (HER2 retry study)
Date of disclosure of the study information 2016/10/21
Last modified on 2018/10/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter observational study on HER2 Status in HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab
KSCC1604 (HER2 retry study)
Acronym Multicenter observational study on HER2 Status in HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab
(HER2 retry study)
Scientific Title Multicenter observational study on HER2 Status in HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab
KSCC1604 (HER2 retry study)
Scientific Title:Acronym Multicenter observational study on HER2 Status in HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab
(HER2 retry study)
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate HER2 status in HER2-positive advanced or recurrent gastric cancer, which is radiologically or clinically diagnosed as progressive disease against trastuzumab treatment, and serach for biomarkers that associate with resistance to trastuzumab.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of HER2 positivity after resistance to trastuzumab treatment
Key secondary outcomes Amplification of EGFR and c-met gene, PIK3CA gene mutation as biomarkers that associate with resistance to trastuzumab.

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 1. The cancer is pathologically confirmed (via resected surgical specimens or biopsied tissue) to be gastric cancer (adenocarcinoma).
2. The patient has advanced/recurrent gastric cancer not amenable to curative surgery.
3. The primary tumor or a metastatic focus was determined to be HER2-Positive before trastuzumab treatment. Positivity for HER2:3+ on an IKC test,or 2+ on an IHC test and positive on a FISH test (If the result of the IHC test is 2+,the result of the FISH test must be positive,i.e.presence of HER2 gene amplification).
4. The cancer is radiologically or clinically diagnosed as progressive disease against trastuzumab treatment at least once by the investigators. Trastuzumab should be administered at least twice as scheduled. The cancer is pathologically confirmed (via resected surgical specimens or biopsied tissue) to be adenocarcinoma within 3 months after the end of trastuzumab treatment without receiving any other antitumor agents.
Key exclusion criteria Patients who are regarded as unsuitable for this study by the investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Saeki
Organization Graduate School of Medical Sciences, Kyusyu University
Division name Department of Surgery and Science
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL 092-641-1151
Email h-saeki@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KSCC Research Secretariat
Organization Clinical Research Support Center Kyushu
Division name KSCC Research Secretariat
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL 092-631-2920
Homepage URL
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Chugai 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)

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 九州大学(福岡県)
国立病院機構九州がんセンター(福岡県)
国立病院機構福岡東医療センター(福岡県)
社会保険田川病院(福岡県)
光晴会病院(長崎県)
出水郡医師会広域医療センター(鹿児島県)
神戸市立医療センター中央市民病院(兵庫県)
高知医療センター(高知県)
九州大学病院別府病院(大分県)
JCHO九州病院(福岡県)
国立病院機構九州医療センター(福岡県)
製鉄記念八幡病院(福岡県)
公立八女総合病院(福岡県)
長崎大学(長崎県)
医理会柿添病院(長崎県)
大分県立病院(大分県)
国立病院機構別府医療センター(大分県)
中津市立中津市民病院(大分県)
今給黎総合病院(鹿児島県)
鹿児島大学(鹿児島県)
鹿児島厚生連病院(鹿児島県)
松山赤十字病院(愛媛県)
田川市立病院(福岡県)
神戸大学(兵庫県)
香川大学(香川県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 21 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
1.ASCO 2018(2018/6/1~5 CHICAGO,ILLINOIS in USA)
Multicenter observational study on re-evaluation of HER2 status in patients with HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab (KSCC1604)
Tomomi Kashiwada
2.The 56th Annual Meeting of JSCO(2018/10/18~20 Yokohama)
Re-evaluation of HER2 status in patients with HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab (KSCC1604)
Takaaki Arigami
3.European Journal of Cancer
Re-evaluation of HER2 status in patients with HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab (KSCC1604) European Journal Of Cancer
Hiroshi Saeki
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
2016 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information Outcome measured
The following clinical information is obtained.
A) Basic case information
Age, Gender, Month and year of birth, ID number
B) Disease information
Clinical Stage, Location of tumor, Pathological diagnosis/HER2 status with pre-treatment specimen, Operation day/pathological diagnosis, Chemotherapy, Dose and duration of trastuzumab treatment, Over all best response, Pathological diagnosis at the time of resistance to trastuzumab
administration)

Management information
Registered date
2016 Year 10 Month 19 Day
Last modified on
2018 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.