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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003719
Receipt No. 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

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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
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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
URL(English) https://upload.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


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