UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002379
Receipt number R000002921
Scientific Title A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion
Date of disclosure of the study information 2009/08/26
Last modified on 2016/03/28 20:34:59

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Basic information

Public title

A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion

Acronym

A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion

Scientific Title

A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion

Scientific Title:Acronym

A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion

Region

Japan


Condition

Condition

Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the feasibility of combined Cx with Palitaxel and Vinorelbin in lung cancer patients with malignant pleural effusion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Overall survival,safety, toxicity, QOL


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

PTX 70mg/m2
VNR 20mg/m2
every 3 weeks 2-6 courses

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 IIIB or IV NSCLC.
2 No prior chemotherapy
3 measurable disease
4 age 20=<
5 performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
6 adequate bone marrow (leukocyte count > 4,000/mm3, <12,000/mm3, neutrophil count >
2,000/mm3, hemoglobin concentration > 9.5g/dL, platelet count > 100,000 /mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase
[AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr) functions.

Key exclusion criteria

1 active concomitant malignancies or infections
2 past history of severe allergic reactions to drugs
3 other serious complications, such as interstitial pneumonia identified by chest X-ray, uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled diabetes mellitus, liver cirrhosis or hypertension

Target sample size

40


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 or person

Institute

Niigata Lung Cancer Treatment Group

Institute

Department

Personal name



Funding Source

Organization

none

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

2009 Year 08 Month 26 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

2008 Year 12 Month 22 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 08 Month 01 Day

Date analysis concluded

2017 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 08 Month 25 Day

Last modified on

2016 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002921


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name