UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002291 |
|---|---|
| Receipt number | R000002717 |
| Scientific Title | Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study. |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2013/08/07 09:22:36 |
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Basic information
Public title
Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Acronym
Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Scientific Title
Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Scientific Title:Acronym
Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Region
| Japan |
Condition
Condition
Urological Cancer with bone metastasis (Hormone resistant prostate cancer, Kidney cancer, urothelial cancer, kidney pelvis and ureteral cancer)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Zoledronic acid was approved for skeletal related event prevention in 2006 in Japan. However, there are no experiences for Japanese patients with urological cancer. We believe to need clinical data collection for efficacy and safety of Zoledronic acid. We planned multi center clinical study of Zoledronic acid.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Total Skeletal Related Events (SRE) incidence during study
Key secondary outcomes
1.SRE free survival
2.Change of bone-marker(urinary NTx, serum BAP, serum I-CTP)
3.Frequency of adverse events
4.Change of QOL score
5. Bone specific progression free survival
6.Change of BMD
7.Prastate-Specific Antigen (PSA) specific progression free survival
8.Overall survival
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
4mg Zoledronic Acid will be administered every 4 weeks for 96 weeks(24 times)
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
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
1. Hormone resistant prostate cancer, renal cell cancer, or urothelial cancer (bladder cancer, renal pelvic and ureteral cancer) patients with bone metastasis diagnosed clinically and pathologically.
2. PS 0-2(ECOG) (include PS 3,4 by bone metastasis)
3. Age: >= 20 years old ;< 85 years old
4. Keeping organ function
5. Taking agreement by document regarding participation for this clinical study
Key exclusion criteria
1.Experience of bisphosphonate administration (orally or iv)
2.Experience of radiation therapy to bone lesion within 3 months.
3.Experience of 89Sr injection
4.Patients suffering from Renal failure
5.Secnod cancer except above target urological cancer
6.Planned invasive dental therapy and under invasive dental therapy
7.Femail during pregnancy or with possible pregnancy. Female during lactation
8.Coexsistence with mental disorder or neurological symptom
9.disqualified by a medical doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Naito |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Urology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-5603
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yokomizo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Urology
Zip code
Address
3-1-1, Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-5603
Homepage URL
yokoa@uro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate School of Medical Sciences, Kyushu 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
Kyushu Univ
UOEH
Harasanshin Hospital
Kurume Univ
Saga Univ
Nagasaki Univ
Nagasaki Municipal Hospital
Nagasaki Genbaku Hospital
Oita Univ
Miyazaki Univ
Kagoshima Univ
Ryukyu Univ
Hokkaido Univ
Nagasaki Med. Center
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
| 2009 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 03 | Day |
Last modified on
| 2013 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002717
