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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040794
Receipt No. R000046555
Scientific Title The single-armed confirmatory trial for immediate effectivity and safety of palliative arterial embolization for painful bone metastases. (JIVROSG/J-SUPPORT 1903)
Date of disclosure of the study information 2020/07/01
Last modified on 2020/07/10

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Basic information
Public title The single-armed confirmatory trial for immediate effectivity and safety of palliative arterial embolization for painful bone metastases. (JIVROSG/J-SUPPORT 1903)
Acronym PALEM trial
Scientific Title The single-armed confirmatory trial for immediate effectivity and safety of palliative arterial embolization for painful bone metastases. (JIVROSG/J-SUPPORT 1903)
Scientific Title:Acronym PALEM trial
Region
Japan

Condition
Condition bone metastases
Classification by specialty
Medicine in general Hematology and clinical oncology Orthopedics
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the immediate efficacy and safety of palliative arterial embolization for painful bone metastases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) pain relief at 72 hours after arterial embolization(TAE)
2) adverse events related to TAE 2 weeks after TAE
Key secondary outcomes

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 Arterial embolization with a spherical embolic material is performed for painful bone metastases.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1)Diagnosed as painful bone metastases
2)Strongest pain site matches the bone metastasis site
3)No spinal cord compression in the bone metastasis site
4)The patient has pain described over 5 in Numerical Rating Scale.
5)The patient already uses opioid analgesics.
6)Radiation therapy has not been performed on the site within 3 months.
7)The patuient has not been started new chemotherapy or
8)Originated cancer is not limited.
9)promising over 1 month alive after treatment
10)eGFR is over 30 ml/min/1.73m2
11)PT-INR is over 1.5 and Platelet count is over 50000/dl.
12)over 20 years old
13)Signed a consent form
Key exclusion criteria 1)Difficult to hold rest position
2)The patient could not describe pain by Numeric Rating Scale.
3)Preexisting disorders of being allergic to iodinated contrast material
4)Cannot stop anticoagulants and antithrombotic drugs.
5)Qualified ineligible patients being this clinical trial by responsible doctor
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Arai
Organization National Cancer Center Hospital East
Division name Department of Diagnostic Radiology
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL 04-7133-1111
Email yarai1976@gmail.com

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Arai
Organization National Cancer Center Hospital East
Division name Department of Diagnostic Radiology
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL 04-7133-1111
Homepage URL
Email yarai1976@gmail.com

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

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan Supportive, Palliative and Psychosocial Oncology Group(J-SUPPORT)
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Hospital East
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
Tel 04-7133-1111
Email yarai1976@gmail.com

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
2020 Year 07 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
2020 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 16 Day
Last modified on
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046555

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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