UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006445 |
|---|---|
| Receipt number | R000007646 |
| Scientific Title | Observational study of serum HER2 in HER2 positive advanced gastric cancer treated with trastuzumab in combination with capecitabine plus cisplatin(XP+H) |
| Date of disclosure of the study information | 2011/09/29 |
| Last modified on | 2017/10/06 13:06:28 |
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Basic information
Public title
Observational study of serum HER2 in HER2 positive advanced gastric cancer treated with trastuzumab in combination with capecitabine plus cisplatin(XP+H)
Acronym
SHERLOCK2 Trial
Scientific Title
Observational study of serum HER2 in HER2 positive advanced gastric cancer treated with trastuzumab in combination with capecitabine plus cisplatin(XP+H)
Scientific Title:Acronym
SHERLOCK2 Trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes of serum HER2 during the chemotherapy.
To evaluate the efficacy and safety of XP+H in the clinical practice for HER2 positive advanced gastric cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of serum HER2
Key secondary outcomes
Progression Free Survival
Safety
Overall response rate
Overall survival
Receive rate of the 2nd line treatment
Complete rate of 2 cycle of XP+H
Relationship between serum HER2 and tissue HER2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease
2) 20 years old or over
3) HER2 positive tumor (IHC or FISH)
4) Eligible for XP+H by the investigator's decision
5) Signed informed consent
Key exclusion criteria
1)Other malignancies within the last 2 years, except for carcinoma in situ or basal cell carcinoma
2)Positive serum pregnancy test in women of childbearing, or lactating women
3)History of psychiatric disability judged by investigator to be clinically significant, precluding informed consent.
4)Serious intercurrent infections
5)Patients whom physician determines as inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Arimura |
Organization
Sapporo Medical University
Division name
1st department of Internal Medicine
Zip code
Address
S1, W16, Chuo-ku, Sapporo City
TEL
011-611-2111
arimura@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayuko Saito |
Organization
Sapporo Medical University
Division name
1st department of Internal Medicine
Zip code
Address
S1, W16, Chuo-ku, Sapporo City
TEL
011-611-2111
Homepage URL
m.saitou@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University 1st department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University 1st department of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study to investigate the changes of serum HER2 in HER2 positive advanced gastric cancer during the chemotherapy.
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007646
