UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Acronym	A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Scientific Title	A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Scientific Title:Acronym	A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Region	Japan

Condition
Condition	Non-Squamous Non-Small Cell Lung Cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Pathological complete resection rate
Key secondary outcomes	Pathological response rate (pRR) Complete resection rate Relapse-free survival (RFS) Overall survival (OS) Safety

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 Maneuver
Interventions/Control_1	Carboplatin + Docetaxel + Bevacizumab day1 q3w 2cycles Surgical operation is performed over 5 weeks after protocol therapy.
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 pathologically confirmed non-squamous non-small cell lung cancer 2) Clinical stage IB- IIIA 3) Age:20-74years old 4) ECOG PS 0-1 5) Patients without previous treatment for lung cancer 6) If the patient underwent therapy, there should be the following interval between the therapy and the registration -Open biopsy,Treatment of injury->2 weeks -Aspiration biopsy,->1 week 7) Sufficient organ function 8) Written IC
Key exclusion criteria	1) History of severe drug allergy 2) Patients with uncontrollable complications 3) Patients with symptomatic Brain metastasis 4) History of hemoptysis ( >= 2.5mL) 5) History of continuous hemosputum 6) Patients with massive pleural and cardiac effusion 7) Patients with uncontrollable peptic ulcer 8) History of myocardial infarction or cerebral infarction 9) Current or previous history of GI perforation 10) Patients with therapeutic anticoagulopathy 11) Pregnancy, breast feeding and suspected pregnancy 12) Active concomitant malignancy 13) Inappropriate patients for this study judged by the physicians
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Middle name Last name Motohiko Furuichi
Organization	Nihon University School of Medicine Itabashi Hospital
Division name	Department of respiratory surgery
Zip code
Address	30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	furuichi.motohiko@nihon-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Motohiko Furuichi
Organization	Nihon University School of Medicine Itabashi Hospital
Division name	Department of respiratory surgery
Zip code
Address	30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	furuichi.motohiko@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine Itabashi Hospital
Institute
Department

Funding Source
Organization	Nihon University School of Medicine Itabashi Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kawaguchi Municipal Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 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	Enrolling by invitation
Date of protocol fixation	2012 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 31 Day
Last modified on	2014 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010364

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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