UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of pemetrexed maintenance with or without bevacizumab after a first line treatment chemotherapy with bevacizumab-carboplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer
Title of the study (Brief title)	BPOP
Region	Japan

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

Objectives
Narrative objectives1	The objective of study is the efficacy and safety of pemetrexed maintenance therapy with or without bevacizumab after completion of bevacizumab + carboplatin + pemetrexed chemotherapy without disease progression in Patients with advanced, metastatic or recurrent NSCLC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression-free survival for 9 months
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	2011/07/01-2014/06/01
Interventions/Control_2	bevacizumab
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Advanced, metastatic or recurrent NSCLC PS(ECOG) 0-1 Additional eligibility criteria included Adequate function of the bone marrow, liver and kidney. All patients provided written informed consent
Key exclusion criteria	interstitial lung disease history of hemoptysis myocardial infarction,unstable angina, stroke, transient ischemic attack significant vascular disease bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation hypertension or history of hypertensive crisis or encephalopathy; known CNS disease, except brain metastases treated with radiotherapy pregnancy abdominal fistula, or gastrointestinal perforation poorly controlled active ulcer known hypersensitivity to drug
Target sample size	110

Research contact person
Name of lead principal investigator	Shun Matsuura
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama, Hamamatsu 431-3192, Japan
TEL
Email

Public contact
Name of contact person
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address
TEL	053-435-2263
Homepage URL
Email

Sponsor
Institute	Internal Medicine 2, Hamamatsu University School of Medicine.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2014 Year 06 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded	2015 Year 12 Month 31 Day

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

Management information
Registered date	2013 Year 02 Month 08 Day
Last modified on	2016 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007786