UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001098 |
|---|---|
| Receipt number | R000001328 |
| Scientific Title | Randomized phase II study of docetaxel plus zoledronic acid versus docetaxel in patients with relapsing or refractory non-small cell lung cancer and bone metastasis |
| Date of disclosure of the study information | 2008/03/26 |
| Last modified on | 2015/08/31 16:03:26 |
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Basic information
Public title
Randomized phase II study of docetaxel plus zoledronic acid versus docetaxel in patients with relapsing or refractory non-small cell lung cancer and bone metastasis
Acronym
Docetaxel plus zoledronic acid in patients with NSCLC
Scientific Title
Randomized phase II study of docetaxel plus zoledronic acid versus docetaxel in patients with relapsing or refractory non-small cell lung cancer and bone metastasis
Scientific Title:Acronym
Docetaxel plus zoledronic acid in patients with NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of docetaxel plus zoledronic acid in patients with relapsing or refractory non-small cell lung cancer and bone metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Safety, Response rate, SRE rate, SRE free survival, Over all survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel plus zoledronic acid
Interventions/Control_2
Docetaxel
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
>NSCLC with bone metastasis
>Previous treatment with one or two chemotherapy regimens
>Measurable lesion
>Adult patients (>20 years of age)
>Performance status 0-2
>Adequate organ functionWritten informed consent
Key exclusion criteria
>Previous treatment with docetaxel or zoledronic acid
>Regular use of corticosteroidOral complication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruyasu Murakami |
Organization
Shizuoka Cancer Center
Division name
Thoracic Oncology
Zip code
Address
Shimonagakubo 1007, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
| 2008 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=24837137
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 | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 26 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001328
