UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002380 |
|---|---|
| Receipt number | R000002922 |
| Scientific Title | Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group |
| Date of disclosure of the study information | 2009/08/25 |
| Last modified on | 2016/03/28 20:36:11 |
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Basic information
Public title
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Acronym
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Scientific Title
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Scientific Title:Acronym
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the response rate and feasibility of Vinorelbin and zoledronate for NSCLC patient with bone metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
SRE: Skeletal Related Events
Key secondary outcomes
Time to SRE, toxicity, response rate, PFS, OS, pain score, and QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vinorelbin 25mg/m2 day 1,8
zoledronate 4mg day1
every 3 weeks
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 histologically or cytologically confirmed NSCLC
2 no prior chemotherapy
3 measurable disease, and had
4 a life expectancy of at least 3 months.
5 age >=70 years
6 performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
7 adequate organ function
adequate bone marrow (leukocyte count > 3,000/mm3, neutrophil count > 1,500/mm3, hemoglobin concentration > 9.0g/dL, platelet count > 100,000 /mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and corrected Ca 8.0<<11.5mg/dL
Key exclusion criteria
1 active concomitant malignancies,infections
2 symptomatic brain metastases
3 past history of severe allergic reactions to drugs
4 interstitial pneumonia identified by chest X-ray
5 bone metastasis or hypercalcemia required immediate treatment
6 other serious complications, such as uncontrolled angina pectoris,myocardial infarction, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
Homepage URL
hy0522@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment 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
| 2009 | Year | 08 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 25 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002922
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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