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

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 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


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

Value
https://center6.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