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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006189
Receipt No. R000007321
Scientific Title Predictive factors in Capecitabine plus CDDP therapy in patients with HER2 negative advanced gastric cancer
Date of disclosure of the study information 2011/09/01
Last modified on 2019/02/20

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Basic information
Public title Predictive factors in Capecitabine plus CDDP therapy in patients with HER2 negative advanced gastric cancer
Acronym HER2 Negative GC
Scientific Title Predictive factors in Capecitabine plus CDDP therapy in patients with HER2 negative advanced gastric cancer
Scientific Title:Acronym HER2 Negative GC
Region
Japan

Condition
Condition HER2 negative advanced gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the predictive factor in Capecitabine plus CDDP therapy for patients with HER2 negative advanced gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Overall response rate
Key secondary outcomes PFS
OS
PFS and OS according to histological type
PFS and OS accoroding to tumor site
Safety

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 Capecitabine plus CDDP therapy
1)Intravenous injection of 80mg/m2 of CDDP on day1
2) Oral administration of 2000mg/m2/day of Capecitabine from day1 to day15
3)Maximum administration of CDDP is six
4)1000 to 2000 ml of hydration during four hours is recommended when administration of CDDP.
This treatment is repeated tri-weekly
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) Histologically confirmed diagnosis of adnenocarcinoma of the stomach
2) IHC 0 or 1, or Fish negative tumor
3) No prior treatment
4) Measurable lesions
5) Taking food orally
6) Performance status 0-2
7) An expected survival of at least 2 months
8) No serious organ dysfunction:
a leukocyte count >3000/ul, <12000/ul
a neutorophil count>1500/ul, a platelet count >100,000/ul, serum concentration of asparate (AST) and alanine aminotransferase (ALT) <100U/l
a serum bilirubin concentration <1.5mg/dl
a serum creatinine concentration<1.5mg/dl
9) All patinets gave written informed consent
Key exclusion criteria 1) Past history of treatments with Capecitabine and CDDP
2) Past history of drug hypersensitivity for 5-FU
3) Serious infectious disease, or uncotrollable diabetes mellitus
4) Interstitial pneumonia, or lung fibrosis
5) Multiple cancers
6) a patients with DPD deficiency
7)pregnancy, intention of pregnancy in female
8)familiy planning
9)ineligibility according to the attending physician
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikara Kunisaki
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikara Kunisaki
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email s0714@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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
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 横浜市立大学附属市民総合医療センター(神奈川県)
横須賀共済病院(神奈川県)
横浜市立みなと赤十字病院(神奈川県)
済生会若草病院(神奈川県)
横須賀市立市民病院(神奈川県)
横浜市立大学附属病院(神奈川県)
藤沢市民病院(神奈川県)
横浜市立市民病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28913549
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 07 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cancer Chemother Pharmacol. 2017 Nov;80(5):939-943. doi: 10.1007/s00280-017-3430-6. Epub 2017 Sep 14.

Management information
Registered date
2011 Year 08 Month 18 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007321

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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