UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer
Title of the study (Brief title)	Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer
Region	Japan

Condition
Condition	Non-squamous,non-small-cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Surgery in general Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with inoperable non-squemous non-small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Down staging rate
Key secondary outcomes	2year survival rate,2-years relapse free survival,Progression free survival,rate of completion of the protocol treatment,Pathologic complete response rate,Complete resection rate,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	CBDCA AUC6(day1)+Pemetrexed 500mg/m2(day1)+Bevacizumab 15mg/kg(day1) q3weeks x2cycles CBDCA AUC6(day1)+ Pemetrexed 500mg/m2 (day1) q3weeks x1cycles Surgical operation is performed over 3 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 cytologically proven non-squamous non small cell lung cancer 2)Patients with StageII(exclusing N0)/III 3)Without previously treatment for lung cancer 4)ECOG Performance status 0-1 5)Age:20 years to less than 75 years 6)Patients who has measurable by RECIST(ver 1.1)criteria 7)Adequate organ function 8)Life expectancy more than 3 months 9)Signed written informed consent
Key exclusion criteria	1)Uncontrolled infection or Serious medical complications 2)Uncontrollable diabetes mellitus 3)Uncontrollable hypertension 4)Therapeutic anticoagulopathy (except Aspirin within 325mg/day) 5)Current or previous history of hemoptysis 6)Evidence of bleeding diathesis or hemoptysis 7)With great vessel invasion 8)Cavity in tumor 9)Uncontrollable gastrointestinal ulceration 10)Current or previous(within the last 1 year) history of GI perforration 11)History of severe heart disease 12)Interstitial pneumonia or pulmonary fibrosis detectableon chest X-ray 13)Multiple primary cancer 14)With a history of drug sensitivity 15)Patients who do not want to take vitamin preparation 16)Serious psychiatric illness or psychological symptom 17)Women who are pregnant, lactating or with childbearing potential 18)Ineligible based on decision of an investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Yukio Sato
Organization	University of Tsukuba
Division name	Faculty of Medicine, Department of Thoracic Surgery
Address	1-1-1 Tennodai,Tsukuba 305-8575, Japan
TEL	029-853-3097
Email	ysato@md.tsukuba.ac.jp

Public contact
Name of contact person	Yukio Sato
Organization	University of Tsukuba
Division name	Faculty of Medicine, Department of Thoracic Surgery
Address	1-1-1 Tennodai,Tsukuba 305-8575 Japan
TEL	029-853-3097
Homepage URL
Email	ysato@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba, Faculty of Medicine, Department of Thoracic Surgery
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

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 11 Month 09 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 11 Month 22 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007992