UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005088 |
|---|---|
| Receipt number | 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 10:12:17 |
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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
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
harada-t@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006050
