UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000014417