UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IIIA Non-Squamous Non-Small Cell Lung Cancer
Title of the study (Brief title)	Phase II Trial of Preoperative Chemotherapy and Bevacizumab
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 assess 3-year disease-free survival in patients with stage IIIA NSCLC treated with preoperative carboplatin, paclitaxel, and bevacizumab followed by surgical resection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	3-year disease free survival
Key secondary outcomes	Rate of completion of the protocol treatment Overall survival Disease-free survival clinical and pathologic response Complete resection rate Toxicity Intraoperative and postoperative complications

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 AUC=5 (Day1) Paclitaxel 200mg/m2 (Day1) Bevacizumab 15mg/kg (Day0 or1) and Surgery
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically proven non-squamous non-small cell lung cancer 2) Patients with resectable stage IIIA (UICC-7th edition) 3) Without previously treatment for lung cancer 4) Age:20-74 5) PS:0-1 6) Expected FEV 1.0 > 1.0L after lung resection 7) Adequate organ function 8) Written informed consent
Key exclusion criteria	1) Active double cancer 2) Current history of hemoptysis 3) Evidence of bleeding diathesis or coagulopathy 4) With great vessel invasion 5) Cavity in tumor 6) History of uncontrollable pericardial effusion 7) History of severe heart disease 8) Current or previous history (within the last 1 year) of symptomatic cerebrovascular disease 9) Active infectious disease in need of intravenous administration of anti-bacterial, anti-fungal, or anti-viral drugs 10) Receiving anticoagulant drug (except Aspirin within 324 mg/day) 11) Uncontrollable Gastrointestinal ulceration 12) Current or previous(within the last 1 year)history of GI perforation 13) Uncontrollable systemic disease (hyper tension or diabetes mellitus) 14) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 15) Peripheral neuropathy > Grade2 16) With a history of drug sensitivity 17) History of pregnancy or lactation 18) No intention to practice birth control 19) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiko Higashiyama
Organization	Osaka International Cancer Institute
Division name	General thoracic surgery
Address	3-1-69 Otemae Chuouku, Osaka
TEL	06-6945-1181
Email	okami-ji@mc.pref.osaka.jp

Public contact
Name of contact person	Jiro Okami
Organization	Osaka International Cancer Institute
Division name	General thoracic surgery
Address	3-1-69 Otemae Chuouku, Osaka
TEL	06-6945-1181
Homepage URL
Email	okami-ji@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
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	2010 Year 11 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 08 Month 12 Day
Anticipated trial start date	2010 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	2010 Year 11 Month 01 Day
Last modified on	2017 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005363