UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of serum HER2 in HER2 positive advanced gastric cancer treated with trastuzumab in combination with capecitabine plus cisplatin(XP+H)
Title of the study (Brief title)	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	Yoshiaki Arimura
Organization	Sapporo Medical University
Division name	1st department of Internal Medicine
Address	S1, W16, Chuo-ku, Sapporo City
TEL	011-611-2111
Email	arimura@sapmed.ac.jp

Public contact
Name of contact person	Mayuko Saito
Organization	Sapporo Medical University
Division name	1st department of Internal Medicine
Address	S1, W16, Chuo-ku, Sapporo City
TEL	011-611-2111
Homepage URL
Email	m.saitou@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University 1st department of Internal Medicine
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 06 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007646