UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Acronym	Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Scientific Title	Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Scientific Title:Acronym	Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of docetaxel/cisplatin/bevacizumab combination therapy in patients with non-squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	adverse events, progression free survival, overall 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	docetaxel/cisplatin/bevacizumab combination 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) pathologically diagnosed non-squamous non-small cell cancer 2) stage III/IV without indication for curative radiothrapy or post-operative reccurent disease 3) aged 20 years or older, under 75 years 4) ECOG PS: 0-1 5) measurable lesion meeting RECIST criteria (version 1.1) 6) no prior treatment except for surgery,EGFR-TKI, palliative radiotherapy 7) adequate organ function 8) life expectancy more than 3 months 9) adequate interval after prior treatments; 2 weeks from radiotherapy, 8 weeks from lobectomy, 4 weeks from exploratory thoracotomy, 2 weeks pleural drainage 10) written informed consent
Key exclusion criteria	1) brain metastasis 2) histroy of hemoptysis 3) serious complication; cardiac disea se, interstitial peumonia, diabetes, active infection 4) massive pleural or pericardial effusion, ascites 5) concomitant malignancy 6) uncontrollable peptic ulcer or GI perforaion within 1 year 7) uncontrollable hypertension 8) anticoagulation therapy 9) inappropriate for this study judged by the attending physician
Target sample size	47

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Ogura
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Respiratory Medicine
Zip code
Address	Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Japan
TEL	045-701-9581
Email

Public contact
Name of contact person	1st name Middle name Last name Terufumi Kato
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Respiratory Medicine
Zip code
Address	Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Japan
TEL	045-701-9581
Homepage URL	http://www.torg.or.jp/
Email	t-kato@kanagawa-junko.jp

Sponsor
Institute	Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization	Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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	2010 Year 10 Month 12 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	No longer recruiting
Date of protocol fixation	2010 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2014 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 11 Day
Last modified on	2013 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005222

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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