Unique ID issued by UMIN | UMIN000003248 |
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Receipt number | R000003929 |
Scientific Title | CBDCA/Docetaxel for recurrent post-operative NSCLC patients:a phase II study of the Niigata Lung Cancer Treatment Group |
Date of disclosure of the study information | 2010/02/24 |
Last modified on | 2016/03/28 20:36:52 |
CBDCA/Docetaxel for recurrent post-operative NSCLC patients:a phase II study of the Niigata Lung Cancer Treatment Group
CBDCA/Docetaxel for recurrent post-operative NSCLC patients:a phase II study of the Niigata Lung Cancer Treatment Group
CBDCA/Docetaxel for recurrent post-operative NSCLC patients:a phase II study of the Niigata Lung Cancer Treatment Group
CBDCA/Docetaxel for recurrent post-operative NSCLC patients:a phase II study of the Niigata Lung Cancer Treatment Group
Japan |
Non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
To evaluate the response rate and feasibility of CBDCA/Docetaxel for recurrent post-operative NSCLC patient.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
progression free survival, overall survival, safety, QOL, relationship between response and expression of type III tublin, ERCC1, RRM1.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Docetaxel 60mg/m2, CBDCA AUC 5 every 3 weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
1 histologically or cytologically confirmed NSCLC
2 recurrent post operative patients
3 measurable disease, and had
4 a life expectancy of at least 3 months.
5 20>=age >75 years
6 performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
7 adequate organ function
adequate bone marrow (leukocyte count 12,000>= >=4,000/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)
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.
35
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
2010 | Year | 02 | Month | 24 | Day |
Unpublished
Terminated
2009 | Year | 09 | Month | 10 | Day |
2010 | Year | 02 | Month | 01 | Day |
2015 | Year | 02 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 09 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2010 | Year | 02 | Month | 24 | Day |
2016 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003929
Research Plan | |
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Research case data | |
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