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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005366
Receipt No. R000006291
Scientific Title A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
Date of disclosure of the study information 2011/04/26
Last modified on 2018/01/04

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Basic information
Public title A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
Acronym A phase II study of trastuzumab added to docetaxel and S-1 for HER2-positive advanced gastric cancer.
Scientific Title A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
Scientific Title:Acronym A phase II study of trastuzumab added to docetaxel and S-1 for HER2-positive advanced gastric cancer.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and tolerability of trasuzumab added to S-1+docetaxel in HER2-positive advanced gastric cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression free survival
Key secondary outcomes safety, objective response rate, overall survival, time to treatment failure

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 Intravenous infusion of trastuzumab (loading dose 8 mg/kg, 6 mg/kg) on day1, Intravenous administration of 40 mg/m2 docetaxel on Day 1, and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Pathological proven adenocarcinoma of inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach
2) HER2-positive tumors
3) Age 20-79 years
4) Measurable disease or non-measurable but assessable disease
5) No prior chemotherapy except for adjuvant chemotherapy with S-1
6) Adequate organ function
7) ECOG performance status<=2
8) Ejection fraction more than 50% by
ultrasound or MUGA
9) Expected more than 3 months survival
10) Sufficient oral intake
11) With written informed consent
Key exclusion criteria 1) with severe allergy to Trastuzumab, S-1 and docetaxel
2) Active infection or other inflammatory disease
3) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
4) Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, uncontrollable diabetes millutus, hypertension, and respiratory insufficiency.
5) History of cardiac disease
6) Dyspnea at rest, due to complications of advanced malignancy or other cardiovascular disease
7) Metastasis to CNS
8) Grade 3-4 peripheral sensory neuropathy
9) pregnant or nursing patient or with intent to bear baby
10) Inappropriate for the trial at the physician's assessment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate school of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL +81-86-235-7257
Email toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Kagawa
Organization Okayama University Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL +81-86-235-7257
Homepage URL
Email skagawa@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s00280-017-3505-4?wt_mc=Internal.Event.1.SEM.ArticleAuthor
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 Completed
Date of protocol fixation
2011 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2017 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 12 Month 26 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 01 Day
Last modified on
2018 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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