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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015431
Receipt No. R000017946
Scientific Title Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.
Date of disclosure of the study information 2014/11/01
Last modified on 2019/04/18

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Basic information
Public title Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.
Acronym Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.
Scientific Title Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.
Scientific Title:Acronym Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.
Region
Japan

Condition
Condition unrecectable or recurrent advanced gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safty and effectivity of low dose nab-paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival(OS),Progression free survival(PFS),Safty, Time to progression(TTP)

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 receive 180mg of nab-paclitaxel per square meter of body-surface area on day 1 of every 21-day cycle. The patients continue therapy until disease progression or prohibitive toxic effects occure.
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.Unresectable or recurrent advanced gastric cancer
2.Histologically confirmed adenocarcinoma, signet ring cell caricinoma and mucinous adenocarinoma.
3.Prior treatment by chemothrapy including 5-FU regimen
4.No central nurve metastasis
5.Age from 20 to 65 years old
6.Performance status is 0,1,2.
7.Required baseline laboratory data.(within 14 days of registration)
Neu 1,500mm3
PLT 100,000mm3
T-Bil 1.5mgdL
AST 100IU/L
ALT 100IU/L
serum creatine 1.5mg/dL
8.Expected survival time more than 90 days
9.The patient has previously given written, informed consent to participate in this study
Key exclusion criteria 1.With history of receiving paclitaxel treatment
2.With serious drug allergy
3.With servaral comorbid disease
poorly controlled diabetes
poorly controlled hypertension
liver cirrhosis, liver failure
renal failure
intestitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
active infectious disease
heart failure, myocardial infarction, angina pectoris or ECG abnormalities within 6 months
4.With active anothor cancer
5.With peripheral neuropathy greater than grade2
6.With HBs antigen positive
7.With pregnant or nursing women
8.Cases who physician judged improper to entry this trial
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Endo
Organization Yokohama City University Hospital
Division name gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Takagawa
Organization Yokohama City University Medical Center
Division name Gastroenerological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email rtakagawa@gmail.com

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)
横浜市立大学附属病院(神奈川県)
横須賀共済病院(神奈川県)
横浜市立市民病院(神奈川県)
藤沢市民病院(神奈川県)
済生会横浜市南部病院(神奈川県)
独立行政法人国立病院機構横浜医療センター(神奈川県)
横浜みなと赤十字病院(神奈川県)
横浜保土ヶ谷中央病院(神奈川県)
横須賀市立市民病院(神奈川県)
伊東市民病院(神奈川県)
NTT東日本関東病院(神奈川県)
済生会若草病院(神奈川県)
横浜掖済会病院(神奈川県)
長津田厚生総合病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 34
Results
Anticancer Res. 2018 Dec;38(12):6911-6917. doi: 10.21873/anticanres.13068.
Results date posted
2019 Year 04 Month 18 Day
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
2014 Year 10 Month 03 Day
Date of IRB
2014 Year 10 Month 08 Day
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 14 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017946

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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