UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006120 |
|---|---|
| Receipt number | R000007222 |
| Scientific Title | A randomised clinical trial of docetaxel and estrogen in patients with castration resistant prostate cancer |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/03/18 12:01:18 |
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Basic information
Public title
A randomised clinical trial of docetaxel and estrogen in patients with castration resistant prostate cancer
Acronym
Docetaxel and Estrogen in CRPC
Scientific Title
A randomised clinical trial of docetaxel and estrogen in patients with castration resistant prostate cancer
Scientific Title:Acronym
Docetaxel and Estrogen in CRPC
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compare the efficacy and safety between two treatment arms each of docetaxel and estrogen as a first induction therapy for CRPC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to treatment failure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemotherapy: Docetaxel 70mg/m2 div. every 4 weeks.
Predonisolone 10mg/day p.o. daily.
Interventions/Control_2
Hormonal therapy: Ethynil estradiol 1.0mg/day p.o. daily.
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) Patients diagnosed as prostate cancer pathologically at the initial treatment. 2)Clinical any T any N any M prostate cancer patient treated by androgen deprivation therapy prior to this trial.
3)Cancer relapse or disease progression must be confirmed after androgen deprivation therapy.
4)Age over 20 years old
5)4) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
6)Major organ function must be conserved before registration.
7)Written informed consent must be obtained from patients.
Key exclusion criteria
1)Patients who received cytotxic-chemotherapy prior to this trial.
2)Patients who received estrogen therapy prior to this trial.
3)Patients who received radiation therapy to primary cancer site within 3 monthsprior to this trial.
4)Patients who diagnosed pulmonary fibrosis or interstitial pneumonitis.
5)Patients who have a history of acute myocardial infarction within 6 months.
6)Severe cormobidity (DM, heart disease, liver dysfunction etc.)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Sakai |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Nephro-Urology
Zip code
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7340
hsakai@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Takehara |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Nephro-Urology
Zip code
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7340
Homepage URL
takehara@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Nephro-Urology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department account fund
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
| 2011 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 08 | Month | 05 | Day |
Last modified on
| 2014 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007222
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
