UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.
Title of the study (Brief title)	A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.
Region	Japan

Condition
Condition	advanced gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the efficacy and safety of paclitaxel with trastuzumab as after first-line chemotherapy for advanced gastric cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	Progression-free survival (PFS), Overall survival(OS), Toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients are recieved paclitaxel plus trastuzumab as after 1st-line chemotherapy.
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	Histologically confirmed HER2 postive: IHC(3+) or IHC(2+) and FISH+ A history of first-line chemotherapy with resistant or recurrent disease At least one measurable target lesion
Key exclusion criteria	central nervous system metastasis other active double cancer inadequately controlled diabetes, heart disease, renal disease or liver disfunction. severe peritoneal metastasis, interstitial pneumonia or pulmonary fibrosis previous history of angina or myocardinal infarction severe drug hypersensitivity bleeding tendency
Target sample size	30

Research contact person
Name of lead principal investigator	Yosuke Horita
Organization	Toyama Prefectural Central Hospital
Division name	Department of chemotherapy
Address	Nishinagae 2-2-78, Toyama city, Toyama 930-8550, Japan
TEL	076-424-1531
Email	york@mud.biglobe.ne.jp

Public contact
Name of contact person	Yosuke Horita
Organization	Toyama Prefectural Central Hospital
Division name	Department of chemotherapy
Address	2-2-78, Nishinagae, Toyama, Japan
TEL	076-424-1531
Homepage URL
Email	york@mud.biglobe.ne.jp

Sponsor
Institute	Toyama Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Toyama Prefectural Central Hospital
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 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 08 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 02 Month 01 Day
Date analysis concluded	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 09 Month 24 Day
Last modified on	2018 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007598