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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007044
Receipt No. 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

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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
Email 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
Email t-inoue@hp.pref.hyogo.jp

Sponsor
Institute Cancer Insutitute in Hyogo prefecture
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008305

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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