UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040794 |
|---|---|
| Receipt number | 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 | 2023/07/11 17:26:23 |
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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)Patient has received some form of analgesic medication for pain relief.
6)Radiation therapy (RT) has not been performed on the site of arterial embolization within 2 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
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
yarai1976@gmail.com
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
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
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
愛知医科大学（愛知県）
愛知県がんセンター （愛知県）
岩手医科大学 放射線科 （岩手県）
がん研究会有明病院 （東京都）
国家公務員共済組合連合会斗南病院 （北海道）
国立がん研究センター中央病院 （東京都）
国立がん研究センター東病院 （千葉県）
静岡県立がんセンター （静岡県）
順天堂大学 （東京都）
聖マリアンナ医科大学 （神奈川県）
手稲渓仁会病院 （北海道）
奈良県立医科大学 （奈良県）
北海道大学病院 （北海道）
琉球大学医学部付属病院 （沖縄県）
・追加参加施設 2022/01 追加
大阪大学 （大阪府）
神戸大学 （兵庫県）
慶応大学病院 （東京都）
済生会福岡総合病院 （福岡県）
市立奈良病院 （奈良県）
函館五稜郭病院 （北海道）
兵庫医科大学病院 （兵庫県）
兵庫県立がんセンター （兵庫県）
福知山市民病院 （京都府）
北海道がんセンター （北海道）
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046555
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| Registered date | File name |
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