Unique ID issued by UMIN | UMIN000005619 |
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Receipt number | R000006638 |
Scientific Title | A phase II study of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients with advanced non-squamous non-small-cell lung cancer |
Date of disclosure of the study information | 2011/05/19 |
Last modified on | 2023/05/27 11:00:18 |
A phase II study of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients with advanced non-squamous non-small-cell lung cancer
A phase II study of Docetaxel with Bevacizumab elderly patients with NSCLC
A phase II study of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients with advanced non-squamous non-small-cell lung cancer
A phase II study of Docetaxel with Bevacizumab elderly patients with NSCLC
Japan |
Non-squamous non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To investigate the efficacy and safety of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients
with advanced non-squamous non-small-cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
RR: response rate
PFS: progression free survival
OS: overall survival
DCR: disease control rate
AE: Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
No treatment
1
Treatment
Medicine |
Six cycles of Docetaxel + Bevacizumab followed by maintenance Bevacizumab until disease progression
70 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients
2) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease
3) Patients aged 70- years
4) ECOG performance status 0-1
5) Adequate organ function
6) Excepted to live over 3 months after administration day
7) Written informed consent from the patients
1) squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) Pleural effusion, pericardial effusion and ascites to need treatment
4) Severe renal function disorder
5) SVC syndrome
6) Brain metastases with neurological symptoms
7) Active double cancer
8) Uncontrollable diabetes mellitus and hypertenson
9) Liver cirrhosis by image findings or laboratory examinations
10) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.)
11) Pregnancy, breast feeding and suspected pregnancy
12) History of grave drug allergic reaction
13) Acute inflammatory disease
14) An agreement is not obtained for support therapy such as transfusion etc
15) Having the bleeding tendency which is clinically apparent
16) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
35
1st name | |
Middle name | |
Last name | Shinzoh Kudoh |
Graduate School of Medicine, Osaka City University
Department of Respiratory Medicine
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3793
y-naruo@sc4.so-net.ne.jp
1st name | |
Middle name | |
Last name | Naruo Yoshimura |
Graduate School of Medicine, Osaka City University
Department of Respiratory Medicine
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3793
y-naruo@sc4.so-net.ne.jp
Osaka Lung Cancer Study Group
None
Self funding
NO
大阪市立大学医学部附属病院
2011 | Year | 05 | Month | 19 | Day |
Partially published
not yet
Terminated
2010 | Year | 10 | Month | 27 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2015 | Year | 11 | Month | 01 | Day |
2015 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2011 | Year | 05 | Month | 18 | Day |
2023 | Year | 05 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006638
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