UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007044 |
|---|---|
| Receipt number | R000008305 |
| Scientific Title | evaluation of intermittent docetaxel chemotherapy in patients with castration-resistant prostate cancer |
| Date of disclosure of the study information | 2012/01/13 |
| Last modified on | 2015/02/16 12:44:49 |
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Basic information
Public title
evaluation of intermittent docetaxel chemotherapy in patients with castration-resistant prostate cancer
Acronym
evaluation of intermittent docetaxel chemotherapy in patients with castration-resistant prostate cancer
Scientific Title
evaluation of intermittent docetaxel chemotherapy in patients with castration-resistant prostate cancer
Scientific Title:Acronym
evaluation of intermittent docetaxel chemotherapy in patients with castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether intermittent docetaxel therapy might control disease while improving the quality of life in patients with castration-resistant prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
time to treatment failure and the duration of drug holidays
quality of life
Key secondary outcomes
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
intermittent docetaxel chemotherapy
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
Key inclusion criteria
1. histologically giagnosed as prostate cancer
2. patients must be announced as prosate cancer
3. patients have not been treated by chemotheraputic agents
4. abscent of myelosuppression, renal dysfunction and hepatic dysfunstion
5. more than 2 months of prognosis is anticipated
6. performance status of ECOG less than 2
7. written informed consent was obtained
Key exclusion criteria
1. patients with active other malignancies at the time of enrollment
2. patients with brain or meningeal metastasis at the time of enrollment
3. patients with nerve disorder more than grade 2 in CTCAE ver4.0 (except for owing to tumor compression)
4. patients with edema more than grade 2 in CTCAE ver4.0
5. patients with pleural effusion, ascites or pericardial effusion that need medical attention
6. patients with allergy to polysorbate80
7. patients with other sever complications
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Inoue |
Organization
Cancer Insutitute in Hyogo prefecture
Division name
Urology
Zip code
Address
13-70 kitaoujimachi, akashi city, Hyogo prefecture, Japan
TEL
078-929-1151
t-inoue@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | takaaki inoue |
Organization
Cancer Insutitute in Hyogo prefecture
Division name
Urology
Zip code
Address
13-70 kitaoujimachi, akashi city, Hyogo prefecture, Japan
TEL
078-929-1151
Homepage URL
t-inoue@hp.pref.hyogo.jp
Sponsor or person
Institute
Cancer Insutitute in Hyogo prefecture
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 10 | Day |
Last modified on
| 2015 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008305
