UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201)
Title of the study (Brief title)	OSAKA-LCSG1201
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 Pemetrexed and Bevacizumab in plutinum unfit patients with untreated non-squamous NSCLC patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression-free survival, 1 year survival rate, Frequency and grade of adverse event

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	Pemetrexed Bevacizumab
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)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer (2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery (3) Patient who unfit platinum (4)Age 20=< (5)ECOG performance status of 0 to 2 (6)With one or more measurable disease based on RECIST (7) Interval -Immune therapy, Endocrine therapy >3wks -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage>1wks -biopsy with dissection, indwelling port >2wks -blood transfusion >2wks (8)Adequate organ function, evaluated within 14 days before enrollment as Neu >= 1,500 /mm3 Plt >= 10.0 x 10000 /mm3 hemoglobin >= 9.0 g/dL T-bil =< 1.5 mg/dL AST (GOT) ,ALT (GPT) =< 100 IU/L Cr >= 1.5mg/dL Proteinuria <1+ SpO2 >= 90% (9)Expected to live over 3 months after administration days. (10)Written informed consent from the patients.
Key exclusion criteria	(1)Symptomatic brain metastasis (2) Have another active malignancy (3) Current or previous history of hemoptysis (4) Evidence of tumor invading large vessel on imaging (5) Evidence of tumor invading trachea or main bronchus on imaging (6) Have received radiation therapy to lesions of lung (7) Currently have or have a history of a cardiac effusion which requires treatment (8) Brain infarction within 1 year (9) Problematic infection (10) Scheduled operation (11) Active radiation pneumonitis or esophagitis (13) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (14) Decision of ineligibility by a physician.
Target sample size	45

Research contact person
Name of lead principal investigator	Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Address	2-15 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3833
Email	tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Masayoshi Higashiguchi
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Address	2-15 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3833
Homepage URL
Email	higashiguchi@imed3.med.osaka-u.ac.jp

Sponsor
Institute	OSAKA-LCSG
Institute
Department

Funding Source
Organization	Nothing
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	2012 Year 12 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 08 Month 30 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 30 Day
Date analysis concluded	2015 Year 11 Month 30 Day

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

Management information
Registered date	2012 Year 12 Month 13 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010360