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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007630
Receipt No. R000008862
Scientific Title A clinical study of bevacizumab to analyze a correlation of efficacy and the VEGF-related gene cluster for Patients with Advanced Non- Squamous Non-Small Cell Lung Cancer -KTOSG1003-
Date of disclosure of the study information 2012/03/31
Last modified on 2012/10/12

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Basic information
Public title A clinical study of bevacizumab to analyze a correlation of efficacy and the VEGF-related gene cluster for Patients with Advanced Non- Squamous Non-Small Cell Lung Cancer -KTOSG1003-
Acronym KTOSG1003 study
Scientific Title A clinical study of bevacizumab to analyze a correlation of efficacy and the VEGF-related gene cluster for Patients with Advanced Non- Squamous Non-Small Cell Lung Cancer -KTOSG1003-
Scientific Title:Acronym KTOSG1003 study
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore the efficacy and positive predictive biomarkers of bevacizumab in patients with advanced 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 Explore the positive predictive biomarkers of bevacizumab
Key secondary outcomes Response rate, Prgression free survival, 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
Interventions/Control_1 Bevacizumab treatment
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)Writtened informed consent
(2)Age of 20 years or older
(3)Performance Status (ECOG) 0-1.
(4)Life expectancy of at least 3 months
(5)Histologically or cytrologically confirmed diagnosis of NSCLC without squamus cell carcinoma
(6)Tumors must have measurable disease by RECIST ver1.1.
(7)adequate organ function.
Key exclusion criteria (1)CNS metastasis.
(2)History of treatment for brain metastasis.
(3)History of active double cancer.
(4)History of hemoptysis or hemosputum.
(5)Evidence of bleeding diathesis or coagulopathy.
(6)With great vessel invasion or cavity in tumor.
(7)Radiotherapy for thoracic lesions.
(8)History of severe heart disease.
(9)Superior vena cava syndrome.
(10)Spinal cord compression
(11)Current or previous history (within the last 1 year) of symptomatic cerebrovascular disease.
(12)Non-healing bone fracture and wound.
(13)Active infectious disease in need of intravenous administration of anti-bacterial, anti-fungal, or anti-viral drugs.
(14)Plan of the operation.
(15)Uncontrollable thrombosis.
(16)Uncontrollable gastrointestinal ulceration.
(17)Current or previous(within the last 1 year)history of GI perforation.
(18)Uncontrollable systemic disease (hyper tension or diabetes mellitus).
(19)Severe cardiac disease.
(20)Interstitial pneumonia or pulmonary fibrosis detectable on X-ray.
(21)Peripheral neuropathy > Grade2.
(22)With a history of drug sensitivity.
(23)History of bevacizumab treatment in the past.
(24)History of pregnancy or lactation.
(25)No intention to practice birth control.
(26)Registration to other trial.
(27)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
1st name
Middle name
Last name Ji-ichirou Sasaki
Organization Kitasato University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1 kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sho Saeki
Organization Kumamoto University Hospital
Division name Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email saeshow@wg7.so-net.ne.jp

Sponsor
Institute Department of Respiratory Medicine,
Kumamoto University Hospital
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 熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 31 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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 15 Day
Date of IRB
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

Other
Other related information Multicenter prospective cohort study

Management information
Registered date
2012 Year 03 Month 31 Day
Last modified on
2012 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008862

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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