UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004028
Receipt number 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 2023/08/23 12:15:45

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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 Makoto
Middle name
Last name Hosono

Organization

Kindai University Faculty of Medicine

Division name

Institute of Advanced Clinical Medicine

Zip code

589-8511

Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Email

hosono@med.kindai.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Hosono

Organization

Kindai University Hospital

Division name

Institute of Advanced Clinical Medicine

Zip code

589-8511

Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Homepage URL


Email

hosono@med.kindai.ac.jp


Sponsor or person

Institute

PMS-89 Study Group

Institute

Department

Personal name



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

Kindai University Hospital

Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan

Tel

072-366-0221

Email

hosono@med.kindai.ac.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

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

Completed

Date of protocol fixation

2010 Year 02 Month 01 Day

Date of IRB

2009 Year 12 Month 10 Day

Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2015 Year 10 Month 05 Day

Date of closure to data entry

2015 Year 12 Month 25 Day

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

2023 Year 08 Month 23 Day



Link to view the page

Value
https://center6.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