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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026121
Receipt No. 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 2017/02/14

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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
Email 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
Email yarai1976@gmail.com

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

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
Email

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
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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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
2017 Year 02 Month 14 Day
Last modified on
2017 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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