UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003719
Receipt number R000004499
Scientific Title A Phase II Study of Paclitaxel+S-1 for previously treated Non-Small Cell Lung Cancer
Date of disclosure of the study information 2010/06/06
Last modified on 2016/07/31 15:04:45

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Basic information

Public title

A Phase II Study of Paclitaxel+S-1 for previously treated Non-Small Cell Lung Cancer

Acronym

A Phase II Study of Paclitaxel+S-1 for previously treated Non-Small Cell Lung Cancer

Scientific Title

A Phase II Study of Paclitaxel+S-1 for previously treated Non-Small Cell Lung Cancer

Scientific Title:Acronym

A Phase II Study of Paclitaxel+S-1 for previously treated Non-Small Cell Lung Cancer

Region

Japan


Condition

Condition

Advanced or relapsed Non-Small Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of Paclitaxel+S- for previously treated Non-Small Cell Lung Cancer

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

Progression free survival
1-year suvival rate
safety


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

Paclitaxel + S-1

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histologically confirmed Non-Small Cell Lung Cancer
2)Advanced Stage (IV or IIIB)
3)With measurable lesion
4)One more prior platinum-based chemotherapy
5)The case of prior Paclitaxel or S-1 treatment is accceptable.
6)20<=, <75 years
7)Performance Status(ECOG):0-1
8)Oral intake is possible
9)Adequate organ functions
10)Patients who have estimated life expectancy longer than 3 months
11)Written informed consent

Key exclusion criteria

1)uncontrollablenangina pectoris, arrythmia or heart failure
2)Hystory of active double cancer
3)complication of superior vena cava syndrome
4)complication ofliver cirrhosis
5)Interstitial pneumonaitis on chest x-ray
6)complication ofgastrointestinal bleeding
7)poorly controled diabetes mellitus
8)symptoms of ileus or watery diarrhea
9)Patients with serious infections or susupected infections with fever
10)complication of massive pericardial effusion, ascites or pleural sffusion
11)Pregnant or lactating woman
12)Symptomatic brain metastasis
13)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumio Imamura

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Pulmonary Oncology

Zip code


Address

1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511

TEL

06-6971-1181

Email

imamura-fu@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazumi Nishino

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Pulmonary Oncology

Zip code


Address

1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511

TEL

06-6972-1181

Homepage URL


Email

nisino-ka@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Osaka University Hospital Department of lung diseases

Name of secondary funder(s)

none


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

大阪大学医学部附属病院(大阪府)大阪府急性期総合医療センター(大阪府)国立病院機構刀根山病院(大阪府)国立病院機構大阪南医療センター(大阪府)公立学校共済組合近畿中央病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2010 Year 06 Month 06 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

2009 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2014 Year 12 Month 31 Day

Date analysis concluded

2015 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 06 Month 06 Day

Last modified on

2016 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name