UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib
Title of the study (Brief title)	A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib
Region	Japan

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

Objectives
Narrative objectives1	Covering analysis including effectiveness and safety of treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and as 2nd-line Erlotinib for patients with StageIIIB/IV non- squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to Treatment Failure
Key secondary outcomes	2nd PFS, Adverse events, Overall survival,

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer 2) stage IIIB/IV or postoperative recurrence patients 3)chemotheraoy naive patients 4)Patients providing written informed consent
Key exclusion criteria	1)Inappropriate patients for this study judged by the physicians
Target sample size	44

Research contact person
Name of lead principal investigator	Yoko Shibata
Organization	Yamagata University School of Medicine
Division name	Department of Cardiology, Pulmonology, and Nephrology
Address	2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL
Email

Public contact
Name of contact person
Organization	Yamagata University School of Medicine
Division name	Department of Cardiology, Pulmonology, and Nephrology
Address	2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL	023-628-5302
Homepage URL
Email

Sponsor
Institute	Yamagata University School of Medicine
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	2011 Year 07 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 05 Month 16 Day
Anticipated trial start date	2011 Year 07 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	Covering analysis including effectiveness and safety of treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and as 2nd-line Erlotinib for patients with StageIIIB/IV non- squamous non-small cell lung cancer

Management information
Registered date	2011 Year 07 Month 29 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007195