Unique ID issued by UMIN | UMIN000002380 |
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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 |
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the response rate and feasibility of Vinorelbin and zoledronate for NSCLC patient with bone metastasis.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
SRE: Skeletal Related Events
Time to SRE, toxicity, response rate, PFS, OS, pain score, and QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Vinorelbin 25mg/m2 day 1,8
zoledronate 4mg day1
every 3 weeks
70 | years-old | <= |
Not applicable |
Male and Female
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
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.
45
1st name | |
Middle name | |
Last name | Hirohisa Yoshizawa |
Niigata University Medical and Dental Hospital
Bioscience Medical Research Center
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
025-227-2517
hy0522@med.niigata-u.ac.jp
1st name | |
Middle name | |
Last name | Hirohisa Yoshizawa |
Niigata University Medical and Dental Hospital
Bioscience Medical Research Center
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
025-227-2517
hy0522@med.niigata-u.ac.jp
Niigata Lung Cancer Treatment Group
none
Self funding
NO
2009 | Year | 08 | Month | 25 | Day |
Unpublished
Terminated
2009 | Year | 04 | Month | 16 | Day |
2010 | Year | 08 | Month | 01 | Day |
2015 | Year | 08 | Month | 01 | Day |
2017 | Year | 08 | Month | 01 | Day |
2017 | Year | 08 | Month | 01 | Day |
2017 | Year | 08 | Month | 01 | Day |
2009 | Year | 08 | Month | 25 | Day |
2016 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002922
Research Plan | |
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