UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011714
Receipt number R000013695
Scientific Title PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Date of disclosure of the study information 2013/09/12
Last modified on 2021/10/19 13:14:49

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Basic information

Public title

PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.

Acronym

PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.

Scientific Title

PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.

Scientific Title:Acronym

PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore efficacy and safety of nab-paclitaxel therapy for elderly patients 75 years or older with recurrence or Stage IIIB/IV with non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival, response rate,
frequency and the degree of the adverse event,QOL


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

Nab-paclitaxel 100mg/m2 on day 1,8,15
Cycles are repeated every three weeks.

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Histologically or cytologically confirmed diagnosis of NSCLC.
2 Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3 No prior chemotherapy
Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted.
Picibanil use for plural effusion is permitted.
4 No prior radiotherapy for primary lesions.(Palliative local radiation except for primary lesion is permitted.)
5 At least one measurable lesion
6 Age of 75 years or older
7 ECOG Performance status of 0-1
8 Adequate organ function
9 Life expectancy of at least 3 months
10 Written informed consent

Key exclusion criteria

1)Active double cancer
2)Active infectious disease
in need of systemic administration of anti-bacterial drugs
3)Uncontrolled psychiatric disease
4)History of Severe drug allergies.
5)Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment.
6)The continuous case that receive it from head to foot of the steroid
7)Severe concurrent disease

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazutoshi Isobe

Organization

Toho University Omori Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Email

kazutoshiisobe@aol.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazutoshi Isobe

Organization

Toho University Omori Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Homepage URL


Email

kazutoshiisobe@aol.com


Sponsor or person

Institute

Toho University Omori Medical Center

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

2013 Year 09 Month 12 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

Completed

Date of protocol fixation

2013 Year 09 Month 01 Day

Date of IRB

2013 Year 09 Month 02 Day

Anticipated trial start date

2013 Year 09 Month 02 Day

Last follow-up date

2021 Year 10 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 11 Day

Last modified on

2021 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013695


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name