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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004028
Receipt No. R000004843
Scientific Title Multicenter prospective Study to determine the efficacy of Strontium-89 for palliation of painful bone metastases in cancer patients
Date of disclosure of the study information 2010/08/10
Last modified on 2010/08/10

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Basic information
Public title Multicenter prospective Study to determine the efficacy of Strontium-89 for palliation of painful bone metastases in cancer patients
Acronym PMS-89
Scientific Title Multicenter prospective Study to determine the efficacy of Strontium-89 for palliation of painful bone metastases in cancer patients
Scientific Title:Acronym PMS-89
Region
Japan

Condition
Condition painful bone metastases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the palliative effect of sorontium-89 for painful bone metastases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Response rate of palliative efficacy based on pain score recorded by patients
Key secondary outcomes Prognostic factor of palliative effect
QOL
Safety

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically/cytologically proven solid tumor
2) Multiple bone metastases consisted with positive site of bone scintigram
3) Baseline pain score was 3 or more.
4) Patient was obtained insufficient effect by analgesics
5) Patient can not adapt to EBRT
6) Life expectancy>=1 month
7) Adequate haematological function:
- Haemoglobin>=9g/dl
- WBC count>=3,000/mm3
- Platelets>=75,000/mm3
8) Written informed consent
Key exclusion criteria 1) severe myelosupppression
2) marked fall of hematological function
3) Administration of Sr-89 within previous 3 months
4) DIC
5) Severe renal disfunction
6) Multiple myeloma
7) Pregnancy
8) Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HOSONO Makoto
Organization Kinki University School of Medicine Hospital
Division name Institute of Advanced Clinical Medicine
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name HOSONO Makoto
Organization Kinki University School of Medicine Hospital
Division name Institute of Advanced Clinical Medicine
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute PMS-89 Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor PMS-89
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 近畿大学医学部附属病院(大阪府)
旭川医科大学(北海道)
大阪医科大学附属病院(大阪府)
大阪府立成人病センター(大阪府)
岡山大学(岡山県)
金沢大学附属病院(石川県)
川崎医科大学(岡山県)
京都市立病院(京都府)
市立堺病院(大阪府)
慶応義塾大学病院(東京都)
神戸大学医学部附属病院(兵庫県)
公立松任石川中央病院(石川県)
聖隷三方原病院(静岡県)
仙台厚生病院(宮城県)
高岡市民病院(富山県)
土浦協同病院(茨城県)
天理よろづ相談所病院(奈良県)
東京医科大学病院(東京都)
東京医療センター(東京都)
東京慈恵会医科大学附属(東京都)
長崎市立市民病院(長崎県)
長野赤十字病院(長野県)
奈良県立大学(奈良県)
西神戸医療センター(兵庫県)
山形大学医学部附属病院(山形県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 10 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
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To extract the prognostic factor of palliative efficacy
To evaluate the effect of QOL
To evaluate the safety

Management information
Registered date
2010 Year 08 Month 10 Day
Last modified on
2010 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004843

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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