UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
Title of the study (Brief title)	A phase I/II study of weekly nab-Paclitaxel/Cisplatin in NSCLC
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 feasibility and efficacy of nab-paclitaxel and cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	objective response rate
Key secondary outcomes	progression free survival, overall survival, toxicity

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	Level 0; nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 60mg/m2 day 1 every 4 weeks Level 1; nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks Level 2; nab-paclitaxel 100mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery 3)EGFR mutation negative, ALK rearrangement negative, other driver oncogenes negative 4)Age: 20- years old 5)ECOG PS 0-1 6)With measurable lesion 7)Adequate organ function 8)Written informed consent
Key exclusion criteria	1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)History of severe drug allergy 3)EGFR mutation positive, ALK rearrangement positive, other driver oncogenes positive 4)History of serious disease condition 5)Symptomatic brain metastasis 6)History of active double cancer 7)History of pregnancy or lactation 8)History of active psychological disease
Target sample size	35

Research contact person
Name of lead principal investigator	Miyako Satouchi
Organization	Hyogo Cancer Center
Division name	Department of Thoracic Oncology
Address	13-70, Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
TEL	078-929-1151
Email	satouchi@hp.pref.hyogo.jp

Public contact
Name of contact person	Yoshihiro Hattori
Organization	Hyogo Cancer Center
Division name	Department of Thoracic Oncology
Address	13-70, Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
TEL	078-929-1151
Homepage URL
Email	hattori@hp.pref.hyogo.jp

Sponsor
Institute	Hyogo Cancer 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)

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 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 30 Day
Anticipated trial start date	2013 Year 10 Month 01 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	2013 Year 09 Month 16 Day
Last modified on	2018 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013617