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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006868
Receipt No. R000008016
Scientific Title Phase II study of efficacy of Bevacizumab plus chemotherapy for malignant pleural effusion (MPE) management of treated or untreated non-squamous non-small lung cancer(NSCLC) patients with uncontrollable MPEs by pleurodesis (NEJ-013B-2)
Date of disclosure of the study information 2011/12/10
Last modified on 2016/12/17

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Basic information
Public title Phase II study of efficacy of Bevacizumab plus chemotherapy for malignant pleural effusion (MPE) management of treated or untreated non-squamous non-small lung cancer(NSCLC) patients with uncontrollable MPEs by pleurodesis (NEJ-013B-2)
Acronym Efficacy of Bevacizumab plus chemotherapy for advanced NSCLC with uncontrollable MPE: Phase II study
(NEJ-013B-2)
Scientific Title Phase II study of efficacy of Bevacizumab plus chemotherapy for malignant pleural effusion (MPE) management of treated or untreated non-squamous non-small lung cancer(NSCLC) patients with uncontrollable MPEs by pleurodesis (NEJ-013B-2)
Scientific Title:Acronym Efficacy of Bevacizumab plus chemotherapy for advanced NSCLC with uncontrollable MPE: Phase II study
(NEJ-013B-2)
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 Our aim was to evaluate efficacy and safety of Bevacizumab plus chemotherapy for controlling MPE of unsuitable or unsuccessful patients with non-squamous NSCLC and MPEs for tube drainage or pleurodesis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE for eight weeksfor eight weeks from the start of treatment
Key secondary outcomes Pleural Progression free survival(PPFS) defined as progression-free survival time (PFS) without reaccumulation of MPE, calculated from the time of starting bevacizumab-based therapy until the day on which pleural effusions increased again, or the day of death regardless of cause; Safty; QOL; Biomarker analysis

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 Two or more cycles of Bevacizumab plus any chemotherapy except tageted therapies
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.historogically or cytologically comfirmed non-squamous NSCLC
2.MPEs cytologically proven (class IV or V) of stage4 or post-operative recurrent patients. 3.unsuitable or unsuccessful patients with non-squamous NSCLC and MPEs for tube drainage or pleurodesis (OK-432, minocycline, etc, except cytotoxic agent).
4. ECOG PS 0-2
5. 20 years old or older
6. adequate organ function
7. Following interval between the below therapie ansd registration; palliative radiotherapy-2weeks or more surgery-4weeks or more open biopsy, treatment of injury and chest tube drainage-1week or more blood transfusion-2weeks or more 8. life expectancy more than 3 months
9. written informed consent
Key exclusion criteria 1.interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2. history of gross hemoptpsis (2.5ml or more) or severe hemosputum (over 1 week, or reciveing hemostatic drug)
3. symptomatic brain metastasis 4.recieving anticoagulant drug (except Aspirin under 324mg/day)
5. scheduled operation
6. invasion to major vessels
7. pulmonary tumor with the cavity
8. severe complication
9. uncontrolled infection
10. Uncontrollable gastriointestinal ulceration
11. history of GI perforation or ulceration (within 1 year)
12.present pregnant or lactation
13. severe drug allegy
14. history of myocardial infarction or cerebral infarction (within 1 year) 15.active concomitant malignancy
16. inappropriate patients judged by the phsicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Gemma
Organization Nippon Medical School
Division name Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Email agemma@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Miyanaga
Organization Nippon Medical School
Division name Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131(6651)
Homepage URL
Email a-miyanaga@nms.ac.jp

Sponsor
Institute North East Japan Study Group
Institute
Department

Funding Source
Organization North East Japan Study Group
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
2011 Year 12 Month 10 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
2011 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 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 12 Month 10 Day
Last modified on
2016 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008016

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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