UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
Title of the study (Brief title)	Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
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 feasibility and efficacy of Carboplatin plus Nab-Paclitaxel in chemotherapy-naive patients with advanced non-small-cell lung cancer and a performance status of 2
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I: Dose limiting toxicity Phase II: Progression free survival
Key secondary outcomes	Phase I: Adverse event, Response rate Phase II: Adverse event, Response rate, Overall survival

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	Carboplatin plus 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) Pathologically confirmation of non-small-cell lung cancer 2) Stage IIIB/IV and chemo-naive non-small-cell lung cancer 3) ECOG PS 2 4) Evaluable lesions 5) Aged 20 or more 6) Adequate organ functions 7) Expected survival over 90 days 8) Written informed consent
Key exclusion criteria	1) Symptomatic brain metastasis 2) Interstitial pneumonia with usual interstitial pneumonia pattern on chest CT 3) Grade 2 or more peripheral sense neuropathy 4) With uncontrolled pleural effusion, ascites or pericardial effusion 5) Treated with palliative radiotherapy within the past two weeks 6) Active concomitant malignancy 7) Severe complication 8) HBs antigen positive 9) Previous severe drug allergy 10) Continuous systemic administration of steroid
Target sample size	33

Research contact person
Name of lead principal investigator	Toshiaki Takahashi
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	(+81)055-989-5222
Email	t.takahashi@scchr.jp

Public contact
Name of contact person	Kazuhisa Nakashima
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	(+81)055-989-5222
Homepage URL
Email	ka.nakashima@scchr.jp

Sponsor
Institute	Shizuoka 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	静岡県立静岡がんセンター（静岡県） 和歌山県立医科大学病院（和歌山県） 倉敷中央病院（岡山県） 広島市立広島市民病院（広島県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 14 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 07 Day
Anticipated trial start date	2014 Year 07 Month 14 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	2014 Year 07 Month 13 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016917