UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014269 |
|---|---|
| Receipt number | R000016583 |
| Scientific Title | Concurrent use of Sr-89 chloride with bone-modifying agent(denosumab, zoledronic acid) is safe and effective for breast cancer patients with painful bone metastases |
| Date of disclosure of the study information | 2014/06/19 |
| Last modified on | 2017/12/19 11:27:52 |
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Basic information
Public title
Concurrent use of Sr-89 chloride with bone-modifying agent(denosumab, zoledronic acid) is safe and effective for breast cancer patients with painful bone metastases
Acronym
Concurrent use of Sr-89 chloride with bone-modifying agent is safe and effective for breast cancer patients with painful bone metastases
Scientific Title
Concurrent use of Sr-89 chloride with bone-modifying agent(denosumab, zoledronic acid) is safe and effective for breast cancer patients with painful bone metastases
Scientific Title:Acronym
Concurrent use of Sr-89 chloride with bone-modifying agent is safe and effective for breast cancer patients with painful bone metastases
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to examine the safety and efficacy of the concurrent use of the radiopharmaceutical strontium-89 (Sr-89) chloride with bone-modifying agent (denosumab, zoledronic acid) for breast cancer patients with painful bone metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence rates of myelotoxicity and hypocalcemia after fourth time uses of bone-modifying agent after use of Sr-89.
Key secondary outcomes
efficacy assessment to evaluated numerical rating scale, analgesic drug dosages, time to SRE, BAP or ALP, tumor marker, bone scintigraphy
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
concurrent use of the Sr-89 with bone-modifying agent (denosumab or zoredronic acid)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.breast cancer diagnosed with histologic or cytologic examination.
2.painful bone metastases indicated by bone scintigraphy .
3.primary medication used for Sr-89.
4.painful or not controlled pain with analgesic.
5. WBC>3000/mm3, neutrophilic leukocyte >1500/mm3, plt>75000/3, Hb>9.0g/dl
6. serum Cr<1.2mg/dl or creatinine clearance>60ml/min
7. Performance Status 0-2
Key exclusion criteria
1. a case indicated chemotherapy
2. a case that has other cancer
3. a case that has grave complication
4. a case that has grave bone marrow suppression
5. a case that has grave renal dysfunction
6. a case that has invasive dental treatment
7. a woman that is pregnant, breast-feed and may be pregnant
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsugawa |
Organization
St. Marianna University School of Medicine
Division name
Breast and Endocrine Surgery
Zip code
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
koitsuga@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Uejima |
Organization
St. Marianna University School of Medicine
Division name
Breast and Endocrine Surgery
Zip code
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
chicoco@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2014 | Year | 06 | Month | 15 | Day |
Last modified on
| 2017 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016583
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| Registered date | File name |
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| Registered date | File name |
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