UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)
Title of the study (Brief title)	Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)
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 Weekly Paclitaxel, Carboplatin and Bevacizumab in patients with 70 years or older non-squamous NSCLC.
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, Disease control rate, Progression free survival, Overall survival, Biomarker analysis, correlation of efficacy with EGFR gene mutation

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	Bevacizumab, Paclitaxel, Carboplatin
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology 2) No prior chemotherapy 3) 70 years or older 4) ECOG-PS 0 or 1 5) At least one or more measurable lesion by RECIST. 6) Adequate organ function 7) Interval -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage>1wks -biopsy with dissection, indwelling port >1wks -blood transfusion >1wks 8) Life expectancy more than three months. 9) Written Informed Consent
Key exclusion criteria	1) History of hemoptysis 2) High risk of bleeding or thrombus events 3) History of anticoagulant within 10 days before enrollment 4) Grade 2 or worse neuropathy 5) Uncontrollable hypertension 6) Symptomatic brain metastasis 7) Uncontrollable pleural effusion or peritoneal effusion 8) Scheduled operation 9) Severe complications 10) Severe infection 11) History of active double cancer 12) No intention to birth control 13) Unstable psychic disorder 14) History of treatment drug 15) History of severe allergic reaction with platinum drug or monoclonal antibody 16) History of allergic reaction with taxan drug, polyoxyethylene or alcohol. 17) Decision of ineligibility by a physician.
Target sample size	36

Research contact person
Name of lead principal investigator	HIrohisa Yoshizawa
Organization	Niigata University Medical & Dental Hospital
Division name	Bioscience Medical Research Center
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2517
Email	hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person	Satoru Miura
Organization	Niigata University Medical & Dental Hospital
Division name	Division of Respiratory Medicine
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2200
Homepage URL
Email	miusat1118@med.niigata-u.ac.jp

Sponsor
Institute	North East Japan Study Group
Institute
Department

Funding Source
Organization	North East Japan Study Group
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	2011 Year 10 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 07 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 06 Month 12 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28150074
Results
Other related information

Management information
Registered date	2011 Year 10 Month 27 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007826