UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab for Advanced Non-small-cell lung cancer
Title of the study (Brief title)	Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab for Advanced Non-small-cell lung cancer
Region	Japan

Condition
Condition	non-squamous non-small-cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigation of efficacy and safety of combination therapy of Pemetrexed/Carboplatin/Bevacizumab and Bevacizumab maintenance therapy for Advanced Non-small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	responce rate
Key secondary outcomes	safety, progression free survival, over all 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	Patients were given Bevacizumab(15mg/kg, div), Pemetrexed(500mg/m2, div) and Carboplatin(AUC=5, div) on day 1, every 4 weeks, up to 6 cycles. Patients who get efficacy above SD without unacceptable toxity, then continuously are treated with Bevacizumab(15mg/kg, div) on day 1, every 4 weeks, until disease progression.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer 2)chemotheraoy naive patients or postoperative recurrence patients without adjuvant chemotherapy excluded UFT treatment 3) stage IIIB/IV(UICC-7) or postoperative recurrence patients 4)mesurrable leision 5)ECOG performance status of 0-2 6)age: 20-75 7)adequate major organ (hemoatologic hepatic, respiratory and renal function) function white blood cell >=3000/mm3 hemoglobin >=9.5g/dl platelet >=100000/mm3 total bilirubin <= 1.5 AST/ALT <=2.5 times upper limit of normal PaO2 >=65 torr or SpO2 >=92% 8)life expectancy more than 3 months 9)written informed consent
Key exclusion criteria	1)Uncontrolled complication unstable angina or myocardiac infarction within 3 months uncontrolled DM and hypertension uncontrolled infection active interstitial pneumonia active gastiric ulcer active concominant cancer illeus 2)patients who cannot been given Bevacizumab with great vessel invasion cavity in tumor current or previous histoty ofhemoptysis(2.5ml)due to NSCLC receiving anticoagulant drug(except Aspirin under 325mg/day) untreated current brain metastasis 3)history of sever allergy 4)severe SVC syndrome 5)uncontrolled malignant pleuritis 6)history of pregnancy or lactation 7)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	38

Research contact person
Name of lead principal investigator	ogura shigeaki
Organization	National Hospital Organization Hokkaido Medical Center
Division name	Department of Respiratory Medicine
Address	yamanote 5-7, Nishi-ku, sapporo
TEL	011-611-8111
Email

Public contact
Name of contact person	ogura shigeaki
Organization	National Hospital Organization Hokkaido Medical Center
Division name	Department of Respiratory Medicine
Address	yamanote 5-7, Nishi-ku, sapporo
TEL	011-611-8111
Homepage URL
Email	sogura@hok-mc.hosp.go.jp

Sponsor
Institute	National Hospital Organization Hokkaido Medical 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	北海道医療センター（北海道）

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 12 Month 07 Day
Anticipated trial start date	2010 Year 12 Month 10 Day
Last follow-up date	2015 Year 03 Month 01 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 08 Day
Last modified on	2019 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005568