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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005088
Receipt No. R000006050
Scientific Title A phase II trial of evaluating the benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity.
Date of disclosure of the study information 2011/02/15
Last modified on 2014/09/09

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Basic information
Public title A phase II trial of evaluating the benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity.
Acronym Benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases.
Scientific Title A phase II trial of evaluating the benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity.
Scientific Title:Acronym Benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases.
Region
Japan

Condition
Condition Non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of zoledronic acid in patients with NSCLC who has bone metastases with elevated urinary NTx. Primary endpoint: Proportion of patients who developed SRE.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Proportion of patients who developed SRE.
Key secondary outcomes 1.Time to first SRE 2.Safety 3.Progression free survival 4.Overall survival 5.Response rate 6.Rate of change of bone marker 7.Rate of change of pain score

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
Medicine
Interventions/Control_1 Zoledronic acid
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

Not applicable
Gender Male and Female
Key inclusion criteria Histologically or cytologically confirmed NSCLC.
Patients who have radiologically apparent bone metastasis.
Patients aged 20 years or older.
ECOG performance status of 0-2.
Sufficient function of main organ filled the following criteria before two weeks from enrollment:
Neu >= 1,500/ mm3
Hb >= 9.0g/dl
Plt >= 100,000/ mm3
T-Bil <= 1.5mg/dl
GOT <= 100IU/ml
GPT <= 100IU/ml
Cre <= 1.5mg/dl.
Urinary NTx> 64nmol/mmol Cr.
Written informed consent.
Key exclusion criteria Patients who need radiotherapy or surgery immediately against bone metastases.
Prior treatment with Sr-89.
Prior bisphosphonates used for cancer.
Patients with symptomatic brain metastasis.
Severe odontopathy.
Interstitial pneumonia on chest x-ray.
Patients with active concomitant malignancy.
Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding. EGFR (+) and planned for EGFR-TKI treatment.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Takayama
Organization Kyushu University, Graduate School of Medical Sciences
Division name Research Institute for Diseases of the Chest
Zip code
Address 3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL 092-642-5378
Email koichi-t@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taishi Harada
Organization Kyushu University, Graduate School of Medical Sciences
Division name Research Institute for Diseases of the Chest
Zip code
Address 3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL 092-642-5378
Homepage URL
Email harada-t@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 飯塚病院(福岡県)
春回会 井上病院(長崎県)
大分県立病院大分県
大分大学大分県
沖縄県立南部医療センター・こども医療センター(沖縄県)
北九州市立医療センター(福岡県)
九州大学(福岡県)
九州大学(福岡県)
済生会福岡第二病院(福岡県)
佐賀県立病院好生館(佐賀県)
佐賀大学(佐賀県)
新別府病院大分県
川内市医師会立市民病院(鹿児島県)
長崎大学(長崎県)
浜の町病院(福岡県)
福岡大学(福岡県)
福岡大学(福岡県)
福岡大学 筑紫病院(福岡県)
国立病院機構 福岡東医療センター(福岡県)
国立病院機構大牟田病院(福岡県)
鹿児島大学(鹿児島県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 15 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 12 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 11 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
2011 Year 02 Month 15 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006050

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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