UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer Previously Treated with Platinum based Chemotherapy
Title of the study (Brief title)	A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer Previously Treated with Platinum based Chemotherapy
Region	Japan

Condition
Condition	Non-Squamous 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 Bevacizumab in combination with docetaxel or S-1 for patients previously treated with 1 regimen platinum-doublet.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Response rate Overall survival Disease control rate Rate of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Docetaxel(60mg/m2)day 1 +Bevacizumab (15mg/kg) day 1 The treatment is repeated every three weeks until disease progression or severe toxicity.
Interventions/Control_2	S-1: 40 mg/m2 twice daily(orally, day1 after dinner ; day15 after breakfast)+ Bevacizumab: 15mg/kg day 1 The treatment is repeated every three weeks until disease progression or severe toxicity.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Non-squamous non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery,who have previously treated platinum doublet. 3)With measurable lesion(RECIST version 1.1) 4)at an interval of more than four weeks from previous treatment 5)If the patient underwent therapy, there should be the following interval between the therapy and the registration i)Radiotherapy other than thoracic radiation ->1 week ii)Palliative radiotherapy including pulmonary field ->3 months iii)Surgery(except CV-port reservation) ->4 weeks iv)Thoracic drainarge ->2 weeks v)Open biopsy, treatment of injury ->2 weeks vi)Aspiration biopsy, CV-port reservation ->1 week 6)Age-> 20 7)ECOG PS 0-1 8)Adequate organ function 9)Life expectancy more than 3 months 10)Written informed consent
Key exclusion criteria	1)interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)history of drug induced interstitial pneumonia 3)history of severe drug allergy 4)patients previously treated with S-1 and docetaxel. 5)history of active infection or other serious disease condition 6)history of poorly controlled pleural effusion,pericardial effusion and ascites 7)history of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,heart failure, etc.) 8)uncontrollable hypertension 9)uncontrollable diabetes mellitus 10)curative radiotherapy pretreated to the chest. 11)current history of hemosputum 12)current or previous history hemoptysis 13)current or previous (within the last 1 year) history of cerebrovascular disease 14)current or previous (within the last 1 year) history of GI perforation 15)symptomatic brain metastasis 16)traumatic fracture of unrecovery 17)the operation has been scheduled for the examination period 18)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor 19)evidence of bleeding diathesis or coagulopathy 20)thrombosis that need to treat 21)severe drug allergy for 80 polysorbate content medicine 22)patients using Flucytosine 23)patients with contraindication of medication (DTX,S-1). 24)history of active double cancer 25)history of active psychological disease 26)history of pregnancy or lactation 27)any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size	90

Research contact person
Name of lead principal investigator	Fumio Imamura
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Pulmonary Oncology
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL	06-6972-1181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	Kazumi Nishino
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Pulmonary Oncology
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL	06-6972-1181
Homepage URL
Email	nisino-ka@mc.pref.osaka.jp

Sponsor
Institute	Hanshin Cancer Study Group
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	大阪府立成人病センター（大阪府） 神戸大学医学部附属病院（兵庫県） 神戸市立医療センター中央市民病院（兵庫県） 京都桂病院（京都府） 国立病院機構刀根山病院(大阪府） 先端医療センター（兵庫県） 兵庫県立がんセンター（兵庫県）

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 15 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete	2014 Year 05 Month 31 Day
Date analysis concluded	2015 Year 02 Month 26 Day

Related information
URL releasing protocol	http://www.sciencedirect.com/science/article/pii/S0169500215002834
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S0169500215002834
Results
Other related information

Management information
Registered date	2010 Year 04 Month 26 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004289