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

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 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


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

Value
https://center6.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