UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003564
Receipt number R000004324
Scientific Title Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804)
Date of disclosure of the study information 2010/05/05
Last modified on 2021/05/13 09:15:05

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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 or person

Institute

Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004324


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name