UMIN-CTR Clinical Trial

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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