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
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
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
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
