UMIN-CTR Clinical Trial

Public title

A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)

Acronym

Percutaneous vertebroplasty for malignant vertebral tumor (JIVROSG-0202)

Scientific Title

A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)

Scientific Title:Acronym

Percutaneous vertebroplasty for malignant vertebral tumor (JIVROSG-0202)

Region

Japan

Condition

Malignant vertebral bone tumor.

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Hematology and clinical oncology	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Chest surgery	Breast surgery	Obstetrics and Gynecology
Orthopedics	Urology	Radiology
Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of percutaneous vertebroplasty for malignant vertebral tumors.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II

Primary outcomes

Adverse events

Key secondary outcomes

Pain evaluated by Visual Analogue Scale (VAS).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the vertebral body involved by malignant tumor and cement is injected.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Primary or metastatic malignant tumor in thoracic or lumber vertebral bone.
2) Severe pain adversely influencing on QOL.
3) No involvement into the spinal canal.
4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
6) Expected survival more than 4 weeks.
7) Written informed consent.

Key exclusion criteria

1) Bleeding time more than 5 minutes.
2) Fever above 38 degrees Celsius.
3) Cardiac failure requiring medication.
4) Active inflammation in vertebrae
5) Severely collapsed vertebrae (less than one third of normal height).
6) No severe pain (less than 2 of VAS).
7) Unable to keep prone position for 1 hour.
8) Necessity of procedure for more than 5 contiguous vertebral bodies.
9) Necessity of single session procedure for more than 4 vertebral bodies.
10) Severe drug allergy.
11) Pregnancy.

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Ken Kobayashi

Organization

Kanazawa University Graduate School of Medicine

Division name

Department of Radiology

Zip code

Address

13-1, Takaramachi, Kanazawa 920-8641, Japan

TEL

076-265-2323

Email

Name of contact person

1st name
Middle name
Last name	Yasuaki Arai

Organization

JIVROSG, Coordinating Office

Division name

Division of Diagnostic Radiology, National Cancer Center Hospital

Zip code

Address

5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan

TEL

03-3542-2511

Homepage URL

http://jivrosg.umin.jp/

Email

jivrosgoffice@ml.res.ncc.go.jp

Institute

Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2005

Year

08

Month

06

Day

URL releasing protocol

http://jivrosg.umin.jp/

Publication of results

Published

URL related to results and publications

http://annonc.oxfordjournals.org/cgi/content/abstract/20/12/1943

Number of participants that the trial has enrolled

Results

Procedures were completed in all 33 patients (42 vertebrae). Thirty days after PVP, two patients died of primary disease progression, but no major adverse reactions (>grade 2) were observed. Response rate was 70% (95% confidence interval 54% to 83%) [61% (n = 20) with SE, 9% (n = 3) with ME, and 30% (n = 10) with NE] and increased to 83% at week 4. Median time to response was 1 day (mean 2.4). Median pain-mitigated survival period was 73 days.

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

Recruitment status

Completed

Date of protocol fixation

2002

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2003

Year

02

Month

01

Day

Last follow-up date

2006

Year

04

Month

01

Day

Date of closure to data entry

2006

Year

05

Month

01

Day

Date trial data considered complete

2006

Year

05

Month

01

Day

Date analysis concluded

2006

Year

10

Month

01

Day

Other related information

Registered date

2005

Year

08

Month

06

Day

Last modified on

2012

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000081