UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC
Title of the study (Brief title)	Phase II clinical study of nab-PTX/CBDCA for patients with clinical stage IIIB/IV or recurrent NSCLC
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effectivity and safty of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC
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	progression free survival/overall survival/disease control rate/adverse events/completion rate of treatment

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) day 1,8,15 + CBDCA (AUC 6 ) day 1 : every 4 weeks (administer 3-weeks on / 1-week off) 4cycles
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.Histologically or cytologically confirmed nonsmall cell lung cancer. 2.clinical stage IIIB/IV or postoperative recurrence. 3.At least one mesurable lesion according to RECISTversion1.1. 4.Chemotherapy-naive patients or postoperative patients without adjuvant chemotherapy until 6 months before the registration. 5.With adequate organ function 5-1.neutrophil count => 1,500/mm^3 5-2.platelet => 100,000/mm^3 5-3.hemoglobin => 9.0g/dL 5-4.AST/ALT <= 2.5 times less than ULN 5-5.T.Bil <= 1.5mg/dL 5-6.serum creatinine <= 1.5mg/dL 5-7.Peripheral neuropathy <= Grade 1 6.Life expectancy of at least 3 months 7.ECOG performance status 0 or 1 8.With written informed consent
Key exclusion criteria	1.With severe myelosuppression. 2.With the history of hypersensitivity for nab-paclitaxel or CBDCA. 3.With active double cancer. 4.With active infectious disease:temperature=>38 5.With clinically important complications. 6.Interstitial pneumonia or pulmonary fibrosis on chest X-rays. 7.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 8.Accepted continuous use of steroid. 9.Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size	5

Research contact person
Name of lead principal investigator	Jun Hanaoka
Organization	Shiga University of Medical Science
Division name	Department of thoracic surgery
Address	Seta-Tsukinowa, Otsu, Shiga
TEL	077-548-2244
Email	hanaoka@belle.shiga-med.ac.jp

Public contact
Name of contact person	Jun Hanaoka
Organization	Shiga University of Medical Science
Division name	Department of thoracic surgery
Address	Seta-Tsukinowa, Otsu, Shiga
TEL	077-548-2244
Homepage URL
Email	hanaoka@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
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)

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	2015 Year 01 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 19 Day
Anticipated trial start date	2015 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 18 Day
Last modified on	2018 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018856