UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007836 |
|---|---|
| Receipt number | R000009233 |
| Scientific Title | Phase II study of palliative radiotherapy combined with Zoledronic Acid Hydrate for metastatic bone tumor from renal cell carcinoma |
| Date of disclosure of the study information | 2012/04/25 |
| Last modified on | 2021/05/20 13:35:17 |
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Basic information
Public title
Phase II study of palliative radiotherapy combined with Zoledronic Acid Hydrate for metastatic bone tumor from renal cell carcinoma
Acronym
Phase II study of Zometa+RT for bone metastasis from RCC
Scientific Title
Phase II study of palliative radiotherapy combined with Zoledronic Acid Hydrate for metastatic bone tumor from renal cell carcinoma
Scientific Title:Acronym
Phase II study of Zometa+RT for bone metastasis from RCC
Region
| Japan |
Condition
Condition
Renal cancer
Classification by specialty
| Orthopedics | Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To report Skeletal related event for bone metastasis treated with radiotherapy and Zoredronic acid hydrate in renal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Skeletal-related event
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 | Device,equipment |
Interventions/Control_1
Radiotherapy+Zoledronic acid hydrate
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
1)Renal cell carcinoma
2)Radiotherapy is planned for bone metastasis
3)No new systematic therapy within 4 weeks
4)White blood cell >=2000/mm3
Platelet >=50000/mm3
Hemoglobin >=8.0g/dl
Creatinine crearance >=30mL/min
5)PS0-2
6)Informed consent
Key exclusion criteria
1)Surgery is needed for bone metastasis
2)Hypercalcemia
3)Dental problem
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Harada |
Organization
Shizuoka Cancer Center
Division name
Radiation Oncology
Zip code
Address
Shimonagakubo1007 Nagaizumi-cho Sunto-gun Shizuoka
TEL
81559895222
h.harada@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Harada |
Organization
Shizuoka Cancer Center
Division name
Radiation Oncology
Zip code
Address
1007 shimonagakubo Nagaizumi-cho, Sunto-gun, Shizuoka, JAPAN
TEL
810559895222
Homepage URL
h.harada@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Japanese Radiation Oncology Study Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Radiation Oncology Study Group
Organization
Division
Category of Funding Organization
Other
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
JROSG11-1
Org. issuing International ID_1
Japanese Radiation Oncology Study Group
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 | 04 | Month | 25 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009233
| 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 |
