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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008124
Receipt No. R000009565
Scientific Title Phase II study of Pemetrexed and Bevacizumab in Performance status 2 patients with advanced non-squamous non-small cell lung cancer.
Date of disclosure of the study information 2012/06/08
Last modified on 2018/06/14

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Basic information
Public title Phase II study of Pemetrexed and Bevacizumab in Performance status 2 patients
with advanced non-squamous non-small cell lung cancer.
Acronym Phase II study of Pemetrexed and Bevacizumab in PS2 patients with advanced non-squamous non-small cell lung cancer.
Scientific Title Phase II study of Pemetrexed and Bevacizumab in Performance status 2 patients
with advanced non-squamous non-small cell lung cancer.
Scientific Title:Acronym Phase II study of Pemetrexed and Bevacizumab in PS2 patients with advanced non-squamous non-small cell lung cancer.
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the response rate and feasibility of Pemetrexed and Bevacizumab in Performance status 2 patients with advanced non-squamous non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes PFS
Key secondary outcomes RR,DCR,OS,TTF,QOL,safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pemetrexed and Bevacizumab administered every 3 week until observation of progression or intolerable toxicity.
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) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology
2) EGFR mutation or ALK rearrangement status is not required
3) No prior chemotherapy
4) 20 years or older and PS 2
5) At least one or more measurable lesion by RECIST ver1.1
6) Adequate organ function
7) Interval
-Palliative radiotherapy >4wks
-Surgery >4wks
-thoracic drainage>1wks
-biopsy with dissection, indwelling port >1wks
-blood transfusion >2wks
8) Life expectancy more than three months.
9) Written Informed Consent
Key exclusion criteria 1) History of hemoptysis
2) High risk of bleeding or thrombus events
3) History of anticoagulant within 10 days before enrollment
4) Active radiation pneumonitis or esophagitis
5) Uncontrollable hypertension
6) Symptomatic brain metastasis
7) Scheduled operation
8) Severe complications
9) Problematic infection
10) History of active double cancer
11) No intention to birth control
12) Unstable psychic disorder
13) History of treatment drug
14) Decision of ineligibility by a physician.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Email hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Homepage URL
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization Niigata Foundation for the Promotion of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
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 燕労災病院(新潟県)
厚生連長岡中央綜合病院(新潟県)
国立病院機構西新潟中央病院(新潟県)
済生会新潟第二病院(新潟県)
上越総合病院(新潟県)
新潟県立がんセンター(新潟県)
新潟県立吉田病院(新潟県)
新潟県立新発田病院(新潟県)
新潟県立中央病院(新潟県)
新潟市民病院(新潟県)
新潟大学医歯学総合病院(新潟県)
新潟労災病院(新潟県)
長岡赤十字病院(新潟県)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 08 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 03 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2016 Year 06 Month 01 Day
Date trial data considered complete
2016 Year 10 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 08 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009565

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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