UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804)
Acronym	Randomized controlled trial of osteoplasty
Scientific Title	Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804)
Scientific Title:Acronym	Randomized controlled trial of osteoplasty
Region	Japan

Condition
Condition	Malignant bone tumor
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical efficacy of percutaneous osteoplasty in patients with painful malignant bone tumor comparing with drug therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Improvement of back pain
Key secondary outcomes	Improvement of health-related QOL/improvement of Roland-Morris Disability Questionnaire: RDQ/ toxicity profile/ survival time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Percutaneous bone plasty (PBP)
Interventions/Control_2	Medical therapy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Painful bone metastases or primary bone tumors in thoracic spine, lumbar spine, or pelvic bones 2. No existing treatment for pain relief other than PBP or medical therapy 3. Palliative prognosis index less than 6. 4. Written informed consent from the patients 5. Twice measurement of health-related quality-of-life and RDQ
Key exclusion criteria	1. Cardiac failure requiring medical therapy 2. Extensive bone destruction in posterior aspect of vertebral bodies or compression of spinal cord by the tumor 4. Bone destruction in acetabulum 5. Uncontrollable bleeding tendency 6. History of advanced drug allergy 7. Active infectious disease 8. Active inflammatory process in intended bone 9. Under radiotherapy for the bone tumor or less than 4 weeks after the completion of RTx without progression of the symptom 10. Indication for strontium-89 radiotherapy 11. Difficulty of keeping treatment position for one hour with medical or physical treatments 12. Incapable in dose escalation of analgesics 13. Pregnancy 14. Contraindication decided by attending physician
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Kobayashi
Organization	Ishikawa Prefectural Central Hospital
Division name	Department of Diagnostic Radiology
Zip code	9208530
Address	Kanazawa-shi, Ishikawa, Japan
TEL	076-237-8211
Email	kobaken@ipch.jp

Public contact
Name of contact person	1st name Yasuaki Middle name Last name Arai
Organization	National Cancer Center Hospital
Division name	Department of Diagnostic Radiology
Zip code	1040045
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL	03-3542-2511
Homepage URL	http://jivrosg.umin.jp/
Email	arai-y3111@mvh.biglobe.ne.jp

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

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Hospital
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
Tel	03-3542-2511
Email	msone@ncc.go.jp

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

愛知県がんセンター中央病院(愛知県）、旭川厚生病院（北海道）、石川県立中央病院（石川県）、岩手医科大学（岩手県）、金沢大学附属病院（石川県）、関西医科大学附属枚方病院（大阪府）、京都第一赤十字病院（京都府）、群馬大学医学部附属病院（群馬県）、神戸大学医学部附属病院（兵庫県）、国立がんセンター中央病院（東京都）、滋賀医科大学（滋賀県）、静岡県立静岡がんセンター（静岡県）、昭和大学横浜市北部病院（神奈川県）、信州大学医学部（長野県）、聖マリアンナ医科大学（神奈川県）、聖路加国際病院（東京都）、手稲渓仁会病院（北海道）、栃木県立がんセンター（栃木県）、獨協医科大学（栃木県）、奈良県立医科大学（奈良県）、福岡大学病院（福岡県）、防衛医科大学校病院（埼玉県）、三重大学医学部附属病院（三重県）、山梨大学医学部附属病院（山梨県）、琉球大学医学部（沖縄県）、国立国際医療センター戸山病院（東京都）、久留米大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 05 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	Enrolling by invitation
Date of protocol fixation	2009 Year 06 Month 08 Day
Date of IRB	2009 Year 09 Month 24 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2020 Year 10 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	2010 Year 05 Month 05 Day
Last modified on	2021 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004324