UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007085 |
|---|---|
| Receipt number | R000008310 |
| Scientific Title | A pilot study of low dose weekly docetaxel metronomic chemotherapy for previously treated advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2012/01/23 |
| Last modified on | 2013/03/10 08:05:44 |
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Basic information
Public title
A pilot study of low dose weekly docetaxel metronomic chemotherapy for previously treated advanced non-small cell lung cancer.
Acronym
A pilot study of low dose weekly docetaxel metronomic chemotherapy for previously treated advanced non-small cell lung cancer.
Scientific Title
A pilot study of low dose weekly docetaxel metronomic chemotherapy for previously treated advanced non-small cell lung cancer.
Scientific Title:Acronym
A pilot study of low dose weekly docetaxel metronomic chemotherapy for previously treated advanced non-small cell lung cancer.
Region
| Japan |
Condition
Condition
previously treated advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a feasibility and survival benefit of low dose docetaxel
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival time
Feasibility
Key secondary outcomes
Objective response rate
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
15mg/m2 of docetaxel was administrated weekly.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologicaly or cytologicaly diagnosed previously treated NSCLC.
Stage-IIIb or IV according to sixth edition of TNM classification at the enrollment.
ECOG PS 0 or 1
(1) WBC>3,000/mm3
(2) neutrophil>1,500/mm3
(3) Hb>8.0 g/dL
(4) platelet>100,000/mm3
(5) total bilirubine<1.5 mg/dL
(6) AST(GOT)<70 IU/L
(7) ALT(GPT)<70 IU/L
(8) serum creatinine<1.5 mg/dL
Key exclusion criteria
1) Patients with active double cancer.
2) Patients with infectious disease.
3) Patients with fever higher than 38 degree.
4) Female under pregnancy or lactation period.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Shimizu |
Organization
Kansai Medical University
Division name
1st department of internal medicine
Zip code
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Shimizu |
Organization
Kansai Medical University
Division name
1st department of internal medicine
Zip code
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
Homepage URL
shimizto@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
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
Secondary IDs
Secondary IDs
YES
Study ID_1
23-7
Org. issuing International ID_1
The Clinical Research Board of Kansai Medical University Takii Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西医科大学附属滝井病院（大阪府）(Kansai Medical University Takii Hospital(Osaka))
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.dovepress.com/articles.php?article_id=9925
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
| 2000 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2000 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2013 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008310
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
