UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Study of Paclitaxel and Carboplatin plus Bevacizumab in StageIIIA-N2, IIIB, IV patients with Nonsquamous Non-Small-Cell Lung Cancer
Acronym	Phase II Study of PTX and CBDCA plus Bevacizumab for Nonsquamous NSCLC
Scientific Title	Phase II Study of Paclitaxel and Carboplatin plus Bevacizumab in StageIIIA-N2, IIIB, IV patients with Nonsquamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym	Phase II Study of PTX and CBDCA plus Bevacizumab for Nonsquamous NSCLC
Region	Japan

Condition
Condition	chemotherapy-naïve StageIIIA-N2, IIIB, IV patients with nonsquamous non-small-cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Evaluation of the efficacy and safety of Paclitaxel, Carboplatin, and Bevacizumab in chemotherapy-naïve StageIIIA-N2, IIIB, IV patients with nonsquamous non-small-cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Endothelial progenitor cells as biomarker Safety Maximum reduction rate of primary tumor size Resectability rate as induction therapy 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	CBDCA AUC=5(day1)+ Paclitaxel 200mg/m 2 (day1)+ Bevacizumab 15mg/kg (day1) q3weeks 2-6cycles Patients who get efficacy above SD without unacceptable toxity, then continuously are treated with Bevacizumab (15mg/kg, div) on day 1, every 3 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically confirmed non-squamous non-small-cell lung cancer 2)Stage IIIA-N2(multipule,bulky)/IIIB/IV without indication for curative radiation therapy 3)No prior systemic treatment advanced NSCLC 4)Performance Status(ECOG) 0-1 5)Patient who has at least one or more measurable lesion by RECIST 6)Patients aged 20 years or older 7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less. *Total bilirubin <=1.5mg/dL. *Serum creatinin, x 1.5 of ULN or less. *Electrocardiogram Nomal *SpO2 >=90% or SaPO2 >=65mmHg *Protein urea >= 1+ 8)Patients who are considered to survive for more than 3 months. 9)interval: (1) Radiation therapy *More than 2 weeks after the last irradiation to other organs. (2)Operation (including pleurodesis) *More than 4 weeks after the operation without Lobectomy (including exploratory surgery) *More than 2 weeks after the last operation (including pleurodesis) 10)Patients providing written informed consent
Key exclusion criteria	1) Radiation therapy(expect chest) 2)Patients with untreated Brain metastases 3)Patients with current or previous history of hemoptysis (2.5mL or more) 4)Patients with uncontrolled hypertension 5)Patients with uncontrolled infection 6)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis 7)Patients with uncontrollable complications 8)Patients with massive pleural or pericardial effusion,or ascites 9)Patients with active concomitant malignancy 10)Patients with previous histories of drug allergy 11)Patients with uncontrollable gastrointestinal ulceration 12)Patients with current or previous (within one year) history of gastrointestinal perforation 13)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) 14)Pregnancy or lactation 15)Inappropriate patients for this study judged by the physicians
Target sample size	31

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Minamiya
Organization	Akita University Graduate School of Medicine
Division name	Department of Chest, Breast and Endocrinologic Surgery
Zip code	0108543
Address	1-1-1 Hondo, Akita, Japan
TEL	018-884-6132
Email	minamiya@med.akita-u.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Imai
Organization	Akita University Graduate School of Medicine
Division name	Department of Chest, Breast and Endocrinologic Surgery
Zip code	0108543
Address	1-1-1 Hondo, Akita, Japan
TEL	018-884-6132
Homepage URL
Email	i-karo@mui.biglobe.ne.jp

Sponsor
Institute	Akita University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Akita University School of Medicine/ Department of Integrated Medicine, Department of Internal Medicine Division of Cardiovascular and Respiratory Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Akita University School of Medicine/
Address	1-1-1 Hondo, Akita, Japan
Tel	018-884-6132
Email	nintei@hos.akita-u.ac.jp

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	秋田赤十字病院 呼吸器外科(秋田県)、秋田組合総合病院 呼吸器内科 呼吸器外科 (秋田県)、中通総合病院 呼吸器外科(秋田県)、由利組合総合病院 呼吸器内科 呼 吸器外科(秋田県)、仙北組合総合病院 呼吸器外科(秋田県)、山本組合病院 呼吸器 内科(秋田県)、能代山本医師会 呼吸器外科(秋田県)、市立秋田総合病院 呼吸器内 科(秋田県)、雄勝中央病院 外科(秋田県)、八戸市立市民病院 呼吸器外科(青森県)、 山形県立新庄病院 外科(山形県)

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
Date of IRB	2011 Year 10 Month 25 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 01 Day
Last modified on	2020 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007916