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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001098
Receipt No. 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

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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
Email

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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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