UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024492 |
|---|---|
| Receipt number | 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 09:06:21 |
* 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
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
kscc2@cres-kyushu.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
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
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
Value
https://center6.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 |
