UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015431 |
|---|---|
| Receipt number | 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 12:57:17 |
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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
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
rtakagawa@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017946
