UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009369 |
|---|---|
| Receipt number | R000011014 |
| Scientific Title | Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis |
| Date of disclosure of the study information | 2012/11/20 |
| Last modified on | 2016/01/13 10:12:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis
Acronym
Zoledronate administration schedule P2 study
Scientific Title
Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis
Scientific Title:Acronym
Zoledronate administration schedule P2 study
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This randomized phase 2 study is conducted to compare bimonthly vs monthly zoledronate in lung cancer patients after 2 months of standard zoledronate therapy.
Primary endpoint: Time to first skeletal related events (SREs), Proportion of patients experiencing SREs, Types of SREs.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to first skeletal related events (SREs), Proportion of patients experiencing SREs, Types of SREs
Key secondary outcomes
Proportion of patients experiencing SREs (first 6 months), Bone marker levels (NTX), Bone pain, Use of analgesics, Safety, Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
International guidelines recommend treatment with bisphosphonates (including zoledronate) in cancer patients with bone metastasis. Standard treatment schedule is 4mg every 4 weeks. We adopted the schedule as a control arm.
Interventions/Control_2
In this study, an experimental arm is a less frequent regimen of zoledronate (4mg every 8 weeks) after 2 months of treatment at the standard dosing schedule.
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
1)Lung cancer patients with radiologically-proven osteolytic bone metastasis
2)Age >= 20 years
3)PS: 0 to 3
4)Estimated CCr: >= 30ml/min
5)Modified serum Ca: 8-11.5 mg/dl
6)Life expectancy of more than 4 months
7)Written informed consent
Key exclusion criteria
1)Patients with a history of intravenous bisphosphonate therapy
2)Uncontrolled co-morbidities and/or infectious diseases
3)Women who are pregnant, have a desire to bear children or in lactation
4)Recent (within 4 weeks) tooth extraction due to dental infection
5)Planned dental or jaw surgery (e.g., extraction, implants)
6)Any other current malignancy or malignancy diagnosed within the past five years.
7)Patients deemed unacceptable for inclusion to the study.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami M.D. |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Integrated Oncology
Zip code
Address
2-2 Minatojima Minami-machi, Chuo-ku, Kobe
TEL
0783045200
shuyoka@fbri.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Fujita M.D. |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Integrated Oncology
Zip code
Address
2-2 Minatojima Minami-machi, Chuo-ku, Kobe
TEL
0783045200
Homepage URL
sfujita@fbri.org
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 20 | 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
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 21 | 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
| 2012 | Year | 11 | Month | 20 | Day |
Last modified on
| 2016 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011014
