Unique ID issued by UMIN | UMIN000002379 |
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Receipt number | R000002921 |
Scientific Title | A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion |
Date of disclosure of the study information | 2009/08/26 |
Last modified on | 2016/03/28 20:34:59 |
A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion
A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion
A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion
A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion
Japan |
Lung Cancer
Pneumology |
Malignancy
NO
The aim of this study is to evaluate the feasibility of combined Cx with Palitaxel and Vinorelbin in lung cancer patients with malignant pleural effusion.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
Overall survival,safety, toxicity, QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
PTX 70mg/m2
VNR 20mg/m2
every 3 weeks 2-6 courses
20 | years-old | <= |
Not applicable |
Male and Female
1 histologically or cytologically confirmed stage IIIB or IV NSCLC.
2 No prior chemotherapy
3 measurable disease
4 age 20=<
5 performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
6 adequate bone marrow (leukocyte count > 4,000/mm3, <12,000/mm3, neutrophil count >
2,000/mm3, hemoglobin concentration > 9.5g/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 pulmonary (PaO2 > 60 torr) functions.
1 active concomitant malignancies or infections
2 past history of severe allergic reactions to drugs
3 other serious complications, such as interstitial pneumonia identified by chest X-ray, uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled diabetes mellitus, liver cirrhosis or hypertension
40
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 | 26 | Day |
Unpublished
Terminated
2008 | Year | 12 | Month | 22 | Day |
2009 | Year | 08 | Month | 01 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | 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=R000002921
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