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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005143
Receipt No. R000006066
Scientific Title A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Date of disclosure of the study information 2011/02/26
Last modified on 2014/09/02

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Basic information
Public title A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Acronym A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Scientific Title A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Scientific Title:Acronym A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy in patients with stage3B/4 nonsquamous non-small-cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes response rate
Key secondary outcomes Progression-free survival(PFS)
Overall survival(OS)
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 Carboplatin and Pemetrexed and Bevacizumab on Day1,every 3 weeks,up to 6 cycles. Achieved disease control without unacceptable toxicity receive Pemetrexed and Bevacizumab on Day1 every 3 weeks, 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non-squamous non small cell lung cancer
2)Patients with Stage3B/4 or postoperative recurrence NSCLC
3)Chemo-na&iuml;ve patient
4)Age:20 years to less than 75 years
5)ECOG Performance status 0-1
6)Patients who has measurable by RECIST(ver1.1)criteria
7)Patients who has the following periods
i.Palliative radiotherapy:1weeks
ii.Operation:4weeks
iii.Thoracic cavity drainage:2weeks
vi.Biopsy with incision,poet custody,and treatment to injury:2weeks
v.Aspiration biopsy cytology:1weeks
8)Adequate organ function
9)Life expectancy more than 3 months
10)Signed written informed consent
Key exclusion criteria 1)Uncontrolled infection or Serious medical complications
2)Uncontrolled pleural effusion or ascites
3)Brain metastases
4)Serious disease condition
5)Uncontrolled diabetes mellitus
6)Therapeutic anticoagulopathy
7)Uncontrolled hyper tension
8)Current or previous history of GI
perforation
9)interstitial lung disease or fibroid lung
10)history of drug-induced interstitial lung diseas
11)Current or previous history of hemoptysis
12)history of hemoptysis
13)Scheduling operation for examination time
14)Treatment history of carboplatin,pemetrexed,bevacizumab
15)Drug allergens
16)Multiple primary cancer
17)Serious psychiatric illness or psychological symptom
18)Women who are pregnant, lactating or with childbearing potential.
19)Ineligible based on decision of an investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University School of Medicine
Division name Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN
TEL 0282-87-2151
Email ishiiysk@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University School of Medicine
Division name Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN
TEL 0282-87-2151
Homepage URL
Email ishiiysk@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Southern Tohoku General Hospital
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 獨協医科大学病院(栃木県)
総合南東北病院(福島県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 26 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
2009 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 01 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
2011 Year 02 Month 25 Day
Last modified on
2014 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006066

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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