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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009966
Receipt No. R000011672
Scientific Title A Multicenter phase II study of Docetaxel combined with Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
Date of disclosure of the study information 2013/02/06
Last modified on 2013/02/06

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Basic information
Public title A Multicenter phase II study of Docetaxel combined with Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
Acronym Phase II study of Docetaxel plus Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous NSCLC.
Scientific Title A Multicenter phase II study of Docetaxel combined with Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
Scientific Title:Acronym Phase II study of Docetaxel plus Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous NSCLC.
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 docetaxel plus bevacizumab for advanced non-squamous NSCLC patients after platinum-based chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Safety, Response rate, 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 and bevacizumab will be administered triweekly until disease progression.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Written informed consent
(2) It is judged by investigators to be treatable in this protocol
(3) Radical radiation therapy cannot adapt (case of clinical stage of a disease IIIB, IV). After failure to first line therapy, platinum doublet
* EGFR-TKI is not regard as a series of first line therapy
* Previously treated with one cytotoxic chemotherapy regimen
* Palliative radiation therapy (gamma-knife, hole brain irradiation, or irradiation to a bone metastatic ) to any place other than the original lesion genesis can register if there is it more than 2 weeks after the radiation therapy(registration is possible from day 15 as day0 on last treatment day)
(4) age>=20years
(5) With measurable lesion(RECIST version 1.1)
(6) ECOG PS 0-2
(7) Adequate organ function WBC >=3,000/mm3,&not; Neu >=1,500/mm3, Platelet >=100,000/mm3 ,Hb >=8.5 g/dl ,ALT,AST <=2.5 x the Upper Limits of Normal (ULN)
(liver metastasis<=5.0 x ULN), T-bilirubin<=1.5 mg/dl , CCr-50 ml/min (Cockcroft & Gault),
ECG (within normal limit) ,SpO2>=94% , Urine protein<= 1+ or 2 g in urine collection for 24h
(8) Life expectancy more than 3 months
Key exclusion criteria (1) Squamous metastasis
(2) No prior platinum-based chemotherapy as first- line therapy
(3) No prior docetaxel or bevacizumab as first- line therapy
(4) Having serious complications.
ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease
(5) Symptomatic brain metastasis
(6) With pulmonary cavitary lesions
(7) Have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer
(8) Having an anamnesis of the following bloody phlegm or complications
* there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage)
(9) Uncontrollable hypertension
(10) Current or previous (within the last 1 year) history of GI perforation
(11) The operation has been scheduled for the examination period
(12) Have multiple primary cancer
(13) History of serious drug hypersensitivity
(14) Pregnancy or lactation
(15) Active psychological disease
(16) Patients who have received a radiation therapy in chest
(17) Receives the steroid continuously(p.o. or i.v.)
(18) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromasa Inoue
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Pulmonary medicine
Zip code
Address 8-35-1 Sakuragaoka Kagoshima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Kanazawa
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Pulmonary medicine
Zip code
Address 8-35-1 Sakuragaoka Kagoshima, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
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)

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
2013 Year 02 Month 06 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 Open public recruiting
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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
2013 Year 02 Month 05 Day
Last modified on
2013 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011672

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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