UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002380
Receipt No. 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

* 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 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
Email 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
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.