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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009756
Receipt No. R000011296
Scientific Title Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer
Date of disclosure of the study information 2013/01/11
Last modified on 2013/01/11

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Basic information
Public title Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer
Acronym JONIE 2 Study
Scientific Title Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer
Scientific Title:Acronym JONIE 2 Study
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare changes of bone resorption marker (NTX) and brief pain inventory (BPI) when given Strontium-89 plus zoledronic acid with zoledronic acid alone painful in bone metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Changes the proportion of patients uNTX at week13
Changes the proportion of patients BPI
Key secondary outcomes Time to SRE were assessed
Dosing of analgesic drug
pain free of proportion patients
changes of bone resorption marker
Time to additional therapy to bone
changes of tumor marker
QOL
Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive zoledronic acid 4mg function IV over 15 minutes infusion every 3-4 weeks for 12weeks (4-5 times infusion).
Interventions/Control_2 Patients receive strontium-89 2MBq/kg(maximum 141MBq) 1-2 miminutes iv on day 1 followed zoledronic acid every 3-4 weeks for 12weeks (3-4 times infusion).
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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Female
Key inclusion criteria 1)Cases of diagnosed breast cancer with bone metastases
2)Cases of diagnosed bone metastases by bone scintigraphy
3)ECOG performance status(PS)is 0 to 2
4)Cases of painful bone metastasis or using analgesic drug for bone pain and well contolled
5)Cases under chemotherapy or previous radiation therapy from outside of the body
6)serum creatinine is lower than 1.2 mg/dL,
creatinine clearance is higher than 60mL/min
7)WBC count is higher than 3,000/mm3,
Neutrophil count is higher than 1,500/mm3,
Platelet count is higher than 75,000/mm3,
Hemoglobin count is lower than 9.0g/dL
8)Not DIC
9)Patients with life expectancy of 12 weeks or longer from the initial registration.
10)Women at least 18 years of age
11)Patients who submitted written informed consent signed by the patient.

Key exclusion criteria 1)Cases with serious myelosupression
2)Cases with serious renal disorder
3)Cases with serious infection or interstitial pneumonia or pulmonary fibrosis
4)Cases with serious drug allergy
5)Cases in use of Denosumab
6)Pregnant patients or patients with possible pregnancy
7)Cases with active primary cancer without bone metastasis
8)Cases under invasive treatment of teeth
9)Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Kohno
Organization Tokyo Medical University Hospital
Division name Breast Oncology
Zip code
Address Nishisinjuku 6-7-1, Shinjuku-ku,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical University Hospital
Division name Breast Oncology
Zip code
Address
TEL
Homepage URL
Email jonie@tokyo-med.ac.jp

Sponsor
Institute JONIE Study Group
Institute
Department

Funding Source
Organization Kobe Breast Cancer Oncology Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 11 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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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

Management information
Registered date
2013 Year 01 Month 11 Day
Last modified on
2013 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011296

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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