UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006868 |
|---|---|
| Receipt number | 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 21:08:34 |
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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
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
a-miyanaga@nms.ac.jp
Sponsor or person
Institute
North East Japan Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008016
