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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013105
Receipt No. R000015281
Scientific Title Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Date of disclosure of the study information 2014/02/10
Last modified on 2021/08/13

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Basic information
Public title Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Acronym Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Scientific Title Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Scientific Title:Acronym Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Region
Japan

Condition
Condition advanced advanced for gastric cancer patients with prior chemotherapy
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of weekly Nab paclitaxel advanced advanced for gastric cancer patients with prior chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Response Rate
Disease Contorol Rate
Overall Survival
Incidence and grade of Adverse Event,

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 Nab paclitaxel(100mg/m2 day1,8,15) every 4 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)Patients with gastric cancer by histological or cytological examination.
2)The case that radical operation is enforced
3)Patients with prior on chemothrapy.
(including recurrence within 6 months after last adjuvant chemotherapy)
4)20 years old or more
5)ECOG performance status<=2
6)More than 2 weeks last chemotherapy
7)Patients with adequately maintained organ functions and fulfilling the following conditions within 21 days before registration
WBC count more than 3,000/mm3 less than , 12,000 /mm3
Neutrophils count more than 1,500/mm3
Hemoglobin more than 8.0 g/dl
Platelet count more than 100,000/mm3
Serum bilirubin level less than 1.5mg/dl
AST and ALT less than 2.5times
8)Patients who provided written informed consent.
9)Patients expected to survive for 90 more than days
Key exclusion criteria 1)patients previously treated with Nab-paclitaxel,paclitaxel derivative drugs
2)peripheral neuropathy
3)History of serious drug hypersensitivity
4)active synchronous malignancy with longer than 5 year interval period
5)Uncontrolled unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia
6)Any other serious illness or medical conditions including interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure,cerebrovascular disordar or Uncontrolled diabates
7)Active infection or fever suspicious of infection.
8)The case that uses a steroid regularly
9)Much amount of pleural effusion, ascites or cardiac effusion
10)Case having extensive bone metastasis
11)with brain metastasis
12)History of mental disorder, central nerve disorder
13)Pregnant women, nursing mothers
14)Patients who were considered by the primary care physician to be inappropriate for this trial
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Nagao
Organization Toho University school of Medicine
Division name Department of Surgery (Ohashi)
Zip code
Address 2-17-6 Ohashi, Meguro-ku, Tokyo
TEL 03-3468-1251
Email jirojirona@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Shimada
Organization Toho University school of Medicine
Division name Division of General and Gastroenterological Surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email hideaki.shimada@med.toho-u.ac.jp

Sponsor
Institute Toho University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2013 Year 11 Month 12 Day
Date of IRB
2013 Year 09 Month 19 Day
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2016 Year 04 Month 05 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 02 Month 07 Day
Last modified on
2021 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015281

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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