Unique ID issued by UMIN | UMIN000005284 |
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Receipt number | R000006285 |
Scientific Title | Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4 |
Date of disclosure of the study information | 2011/03/22 |
Last modified on | 2013/03/18 18:43:21 |
Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Phase2 study of CBDCA / PTX + Bevacizumab to non-small-cell lung cancer with pleural efussion
Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Phase2 study of CBDCA / PTX + Bevacizumab to non-small-cell lung cancer with pleural efussion
Japan |
non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Pneumology |
Malignancy
NO
we rospectivelyexamine the efficacy and safety of Carboplatin / Paclitaxel + bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Safety
Phase II
efficacy
Density of chest underwater VEGF before and after, overall survival time, safety, 1-year survival rate, frequency of chest water drainage, progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin/paclitaxel+bevacizumab
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically confirmed Stage IV Non-small-cell lung cancer
2)Non-Squamous Non-small-cell lung cancer
3)Pleural effusion requiring drainage
4)Adjuvant chemotherapy is permitted
5)At least one year has to be past since the last administration of adjuvant chemotherapy
6)Age : 20 years or older
7)At least one measurable lesion by RECIST
8)PS : 0-2
9)adequate major organ (hemoatologic hepatic, respiratory and renal function) function
white blood cell >=3000/mm3
hemoglobin >=9.0g/dl
platelet >=100000/mm3
total bilirubin <= 1.5
AST/ALT <=2.0 times upper limit of normal
SpO2 >=90%
Adequate organ function
10)Life expectancy more than three months
11)Adequate interval since the last radiation therapy or surgery
12)written informed consent
1)History of pleurodesis
2)Severe infection except for non-active hepatitis C
3)Fever more than 38 degree
4)Severe comorbidity (heart failure/kidney failure/hepatic failure/uncontrollable diabetes/uncontrollable hypertension, etc)
5)Active double cancer
6)Symptomatic brain metastasis
7)History of hemoptysis with 2.5mL or more
8)Pericardial effusion requiring drainage
9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray
10)History of drug sensitivity
11)Pregnant or lactating women
12)Psychiatric disease or mental trouble
13)Continuing administration of steroid
14)Evaluated to be ineligible by a physician for other reasons
20
1st name | |
Middle name | |
Last name | Tomonori Hirashima |
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Thoracic Malignancy
3-7-1 Habikino Habikino city Osaka
1st name | |
Middle name | |
Last name | Motohiro Tamiya |
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Thoracic Malignancy
3-7-1 Habikino Habikino city Osaka
072-957-2121
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
none
Self funding
NO
2011 | Year | 03 | Month | 22 | Day |
Unpublished
Completed
2010 | Year | 08 | Month | 02 | Day |
2010 | Year | 09 | Month | 01 | Day |
2013 | Year | 03 | Month | 14 | Day |
2011 | Year | 03 | Month | 21 | Day |
2013 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006285
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