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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012343
Receipt No. R000014417
Scientific Title Phase II study of nab-paclitaxel for relapsed non-small cell lung cancer (NLCTG1302)
Date of disclosure of the study information 2013/11/19
Last modified on 2019/08/06

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Basic information
Public title Phase II study of nab-paclitaxel for relapsed non-small cell lung cancer
(NLCTG1302)
Acronym Phase II study of nab-PTX for relapsed NSCLC(NLCTG1302)
Scientific Title Phase II study of nab-paclitaxel for relapsed non-small cell lung cancer
(NLCTG1302)
Scientific Title:Acronym Phase II study of nab-PTX for relapsed NSCLC(NLCTG1302)
Region
Japan

Condition
Condition non small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of nab-PTX in relapsed NSCLC patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Safety, Progression free survival, Disease control rate, Overall survival, Evaluation of sensory neuropathy using PNQ score

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
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Non-small cell lung cancer proven by histology and/or cytology
2)EGFR mutation or ALK rearrangement status is not required
3)One or two prior cytotoxic chemotherapy
4)20 years or older
5)Performance Status 0-2
6)At least one or more measurable lesion by RECIST ver1.1
7)Adequate organ function
8)Life expectancy more than twelve weeks.
9)Written Informed Consent
Key exclusion criteria 1)History of paclitaxel treatment
2)Severe complications
1:Type 2 DM treated with insulin injection
2:Symptomatic congestive heart failure or unstable angina or problematic arrhythmia or history of acute myocardial infarction within one year
3:Interstitial pneumonia or active radiation pneumonia or drug-induced pneumonia

3)Problematic infection
4)History of active double cancer
5)Severe drug allergy
6)No intention to birth control
7)Unstable psychic disorder
8)Decision of ineligibility by a physician.
Target sample size 65

Research contact person
Name of lead principal investigator
1st name Hirohisa
Middle name
Last name Yoshizawa
Organization Niigata University Medical & Dental Hospital
Division name Bioscience Medical Research Center
Zip code 9518520
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL 025-227-2517
Email nnys@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Miura
Organization Niigata University Medical & Dental Hospital
Division name Department of Medicine (II)
Zip code 951-8510
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL 025-227-2200
Homepage URL
Email miusat1118@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
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 Niigata University Medical and Dental Hospital Trial Review Committee
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
Tel 025-227-2422
Email chiken-c@med.niigata-u.ac.jp

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
2013 Year 11 Month 19 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 65
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 08 Month 09 Day
Date of IRB
2013 Year 08 Month 27 Day
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2018 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 19 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014417

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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