UMIN-CTR Clinical Trial

Basic information
Public title	PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Acronym	PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Scientific Title	PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Scientific Title:Acronym	PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Region	Japan

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

Objectives
Narrative objectives1	To explore efficacy and safety of nab-paclitaxel therapy for elderly patients 75 years or older with recurrence or Stage IIIB/IV with non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, response rate, frequency and the degree of the adverse event,QOL

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 on day 1,8,15 Cycles are repeated every three 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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Histologically or cytologically confirmed diagnosis of NSCLC. 2 Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 3 No prior chemotherapy Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted. Picibanil use for plural effusion is permitted. 4 No prior radiotherapy for primary lesions.(Palliative local radiation except for primary lesion is permitted.) 5 At least one measurable lesion 6 Age of 75 years or older 7 ECOG Performance status of 0-1 8 Adequate organ function 9 Life expectancy of at least 3 months 10 Written informed consent
Key exclusion criteria	1)Active double cancer 2)Active infectious disease in need of systemic administration of anti-bacterial drugs 3)Uncontrolled psychiatric disease 4)History of Severe drug allergies. 5)Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 6)The continuous case that receive it from head to foot of the steroid 7)Severe concurrent disease
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazutoshi Isobe
Organization	Toho University Omori Medical Center
Division name	Department of Respiratory Medicine
Zip code
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Email	kazutoshiisobe@aol.com

Public contact
Name of contact person	1st name Middle name Last name Kazutoshi Isobe
Organization	Toho University Omori Medical Center
Division name	Department of Respiratory Medicine
Zip code
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Homepage URL
Email	kazutoshiisobe@aol.com

Sponsor
Institute	Toho University Omori 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

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 12 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 09 Month 01 Day
Date of IRB	2013 Year 09 Month 02 Day
Anticipated trial start date	2013 Year 09 Month 02 Day
Last follow-up date	2021 Year 10 Month 19 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 09 Month 11 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013695