UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013329
Receipt number R000015553
Scientific Title Phase2 study of Carboplatin / Nab-paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion
Date of disclosure of the study information 2014/03/05
Last modified on 2021/01/25 18:24:30

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Basic information

Public title

Phase2 study of Carboplatin / Nab-paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion

Acronym

Phase2 study of CBDCA / Nab-PAC + Bevacizumab to non-small-cell lung cancer with malignant pleural efussion

Scientific Title

Phase2 study of Carboplatin / Nab-paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion

Scientific Title:Acronym

Phase2 study of CBDCA / Nab-PAC + Bevacizumab to non-small-cell lung cancer with malignant pleural efussion

Region

Japan


Condition

Condition

non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion in stage4

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

we rospectivelyexamine the efficacy and safety of Carboplatin / Nab-Paclitaxel + bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion in stage4

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

efficacy

Key secondary outcomes

Density of chest underwater VEGF before and after chemotherapy, overall survival time, safety, 1-year survival rate, progression free survival


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/nab-paclitaxel+bevacizumab

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)Histologically or cytologically confirmed Stage IV Non-small-cell lung cancer
2)Non-Squamous Non-small-cell lung cancer
3)Malignant pleural effusion requiring drainage
4)Adjuvant chemotherapy is permitted
5)At least one year has to be past since the last administration of adjuvant chemotherapy
6)Age : 20 years or older
7)At least one measurable lesion by RECIST
8)PS : 0-2
9)adequate major organ (hemoatologic hepatic, respiratory and renal function) function
white blood cell >=3000/mm3
hemoglobin >=9.0g/dl
platelet >=100000/mm3
total bilirubin <= 1.5
AST/ALT <=2.0 times upper limit of normal
SpO2 >=90%
Adequate organ function
10)Life expectancy more than three months
11)Adequate interval since the last radiation therapy or surgery
12)written informed consent

Key exclusion criteria

1)History of pleurodesis or pleural effusion drainage
2)Severe infection except for non-active hepatitis C
3)Fever more than 38 degree
4)Severe comorbidity (heart failure/kidney failure/hepatic failure/uncontrollable diabetes/uncontrollable hypertension, etc)
5)Active double cancer
6)Symptomatic brain metastasis
7)History of hemoptysis with 2.5mL or more
8)Pericardial effusion requiring drainage
9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray
10)History of drug sensitivity
11)Pregnant or lactating women
12)Psychiatric disease or mental trouble
13)Continuing administration of steroid
14)Evaluated to be ineligible by a physician for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirashima Tomonori

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

Division name

Thoracic Malignancy

Zip code


Address

3-7-1 Habikino Habikino city Osaka

TEL

+81-729-57-2121

Email

hirashimat@opho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tamiya Motohiro

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

Division name

Thoracic Malignancy

Zip code


Address

3-7-1 Habikino Habikino city Osaka

TEL

+81-729-57-2121

Homepage URL


Email

moto19781205@yahoo.co.jp


Sponsor or person

Institute

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

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

2014 Year 03 Month 05 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

Terminated

Date of protocol fixation

2014 Year 02 Month 28 Day

Date of IRB

2014 Year 02 Month 28 Day

Anticipated trial start date

2014 Year 03 Month 06 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 04 Day

Last modified on

2021 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015553


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name