UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026121 |
|---|---|
| Receipt number | R000029134 |
| Scientific Title | Multi-center phase II clinical trial of transarterial embolization using microsphere for painful bone tumors (JIVROSG-1106) |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2020/06/16 23:14:09 |
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Basic information
Public title
Multi-center phase II clinical trial of transarterial embolization using microsphere for painful bone tumors (JIVROSG-1106)
Acronym
BoneTACE-II(JIVROSG-1106)
Scientific Title
Multi-center phase II clinical trial of transarterial embolization using microsphere for painful bone tumors (JIVROSG-1106)
Scientific Title:Acronym
BoneTACE-II(JIVROSG-1106)
Region
| Japan |
Condition
Condition
painful bone tumors
Classification by specialty
| Hematology and clinical oncology | Orthopedics | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and the efficacy of transarterial embolization using microsphere for painful bone tumors as a palliative therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of pain reduction at 2 weeks after the procedure.
Key secondary outcomes
Frequency and grade of complications.
Duration of effective pain reduction.
Rate of significant pain reduction at 2 weeks after the procedure.
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
| Maneuver |
Interventions/Control_1
Transarterial embolization using microsphere for patients with painful bone tumors.
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. Patients with primary or metastatic bone lesions.
2. Patient with pain due to the bone lesions.
3. Pain score (Numeric Rating Scale: NRS) >=6.
4. Palliative Prognostic Index(P.P.I.)<6.
5. Refractory, recurrent, or no indication for radiation therapy.
6. Adequate organ function within 2weeks
WBC>=3000/mm3
Plt>=50000/mm3
Hgb>=8.0g/dl
Cr=<2.0mg/dl
Bil=<2.0mg/dl
7. Age >= 20 years
8. Written informed consent obtained prior to registration.
Key exclusion criteria
1. Allergy to contrast media.
2. Active infection other than virus hepatitis.
3. Displaced fracture.
4. Uncontrollable pain due to the non-target bone lesion.
5. Radicular pain due to the target lesion.
6. Undetermined location of the pain.
7. Undetermined location of the target lesion on images.
8. Radiation therapy within 4 weeks.
9. Intent of preoperative embolization for bleeding control.
10. Need for transarterial therapies in 2 weeks after procedure.
11. Inability to keep the position during the procedure with drugs and physical therapies.
12. Uncontrollable coagulation disorders.
13. Pregnancy or possibility of pregnancy.
14. The physician in charge considers the patient unsuitable as the subject of this clinical trial.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Arai |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
aria-y3111@mvh.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Arai |
Organization
St.Mariannna University school of Medicine
Division name
Department of Radiology
Zip code
Address
2-16-1 Sugao Miyamae-ku kawasaki-shi Kanagawa
TEL
044(977)8111
Homepage URL
yarai1976@gmail.com
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
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
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
| 2017 | Year | 03 | 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
3
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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 02 | Month | 14 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029134
