UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002291
Receipt number R000002717
Scientific Title Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Date of disclosure of the study information 2009/08/10
Last modified on 2013/08/07 09:22:36

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Basic information

Public title

Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.

Acronym

Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.

Scientific Title

Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.

Scientific Title:Acronym

Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.

Region

Japan


Condition

Condition

Urological Cancer with bone metastasis (Hormone resistant prostate cancer, Kidney cancer, urothelial cancer, kidney pelvis and ureteral cancer)

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Zoledronic acid was approved for skeletal related event prevention in 2006 in Japan. However, there are no experiences for Japanese patients with urological cancer. We believe to need clinical data collection for efficacy and safety of Zoledronic acid. We planned multi center clinical study of Zoledronic acid.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Total Skeletal Related Events (SRE) incidence during study

Key secondary outcomes

1.SRE free survival
2.Change of bone-marker(urinary NTx, serum BAP, serum I-CTP)
3.Frequency of adverse events
4.Change of QOL score
5. Bone specific progression free survival
6.Change of BMD
7.Prastate-Specific Antigen (PSA) specific progression free survival
8.Overall survival


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

4mg Zoledronic Acid will be administered every 4 weeks for 96 weeks(24 times)

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

85 years-old >

Gender

Male

Key inclusion criteria

1. Hormone resistant prostate cancer, renal cell cancer, or urothelial cancer (bladder cancer, renal pelvic and ureteral cancer) patients with bone metastasis diagnosed clinically and pathologically.
2. PS 0-2(ECOG) (include PS 3,4 by bone metastasis)
3. Age: >= 20 years old ;< 85 years old
4. Keeping organ function
5. Taking agreement by document regarding participation for this clinical study

Key exclusion criteria

1.Experience of bisphosphonate administration (orally or iv)
2.Experience of radiation therapy to bone lesion within 3 months.
3.Experience of 89Sr injection
4.Patients suffering from Renal failure
5.Secnod cancer except above target urological cancer
6.Planned invasive dental therapy and under invasive dental therapy
7.Femail during pregnancy or with possible pregnancy. Female during lactation
8.Coexsistence with mental disorder or neurological symptom
9.disqualified by a medical doctor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiji Naito

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Urology

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan

TEL

+81-92-642-5603

Email



Public contact

Name of contact person

1st name
Middle name
Last name Akira Yokomizo

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Urology

Zip code


Address

3-1-1, Higashi-ku, Fukuoka, Japan

TEL

+81-92-642-5603

Homepage URL


Email

yokoa@uro.med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of Urology, Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyushu Univ
UOEH
Harasanshin Hospital
Kurume Univ
Saga Univ
Nagasaki Univ
Nagasaki Municipal Hospital
Nagasaki Genbaku Hospital
Oita Univ
Miyazaki Univ
Kagoshima Univ
Ryukyu Univ
Hokkaido Univ
Nagasaki Med. Center

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

2009 Year 08 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2007 Year 04 Month 07 Day

Date of IRB


Anticipated trial start date

2007 Year 10 Month 01 Day

Last follow-up date

2012 Year 07 Month 31 Day

Date of closure to data entry

2012 Year 07 Month 31 Day

Date trial data considered complete

2012 Year 12 Month 10 Day

Date analysis concluded

2013 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2009 Year 08 Month 03 Day

Last modified on

2013 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002717


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name