Unique ID issued by UMIN | UMIN000008811 |
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Receipt number | R000010315 |
Scientific Title | Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer. |
Date of disclosure of the study information | 2013/09/01 |
Last modified on | 2017/12/24 16:09:22 |
Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Bevacizumab With Cisplatin Plus Pemetrexed for Asymptomatic Brain Metastases in Non-Sq NSCLC
Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Bevacizumab With Cisplatin Plus Pemetrexed for Asymptomatic Brain Metastases in Non-Sq NSCLC
Japan |
Non-squamous Non-small Cell Lung Cancer
Medicine in general | Pneumology | Hematology and clinical oncology |
Malignancy
NO
To investigate the efficacy and safety of bevacizumab with cisplatin plus pemetrexed as front-line chemotherapyin non-squamous non-small cell lung cancer patients with asymptomatic brain metastases
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Progression-free survival
1. Overall survival
2. Response rate
3. Disease control rate
4. Progression free survival, response rate, and disease control rate
of brain metastases
5. Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bevacizumab (15mg/kg, day 1) with cisplatin (75mg/m2, day 1) plus pemetrexed (500mg/m2, day 1) is administered every three weeks until four cycles. After the completion of four cycles, bevacizumab (15mg/kg, day 1) plus pemetrexed (500mg/m2, day 1) is administered every three weeks as a maintenance therapy.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Stage IIIB, stage IV or recurrent disease after surgery
3)Asymptomatic brain metastases less than 2 cm diameter without urgent local therapy. Extra brain lesion: With measurable or inmeasurable lesion
4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration
i)Radiotherapy including pulmonary field: not permissible ii)Radiotherapy other than thoracic radiation ->1 week
5)Over 20 years old
6)ECOG PS 0-1
7)Adequate organ function
8)Life expectancy more than 3 months
9)Written informed consent
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of severe drug allergy
3)History of active infection or other serious disease condition
(GI bleeding,etc.)
4)History of poorly controlled pleural effusion,pericardial effusion and ascites
5)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.)
6)Uncontrollable hypertension
7)Uncontrollable diabetes mellitus
8)Hystory of active double cancer
9)Invasion to main blood vessels
10)History of active psychological disease
11)Severe hemoptysis or blood sputum
12)History of gastrointestinal perforation
13)Symptomatic or more than 2 cm diameter brain metastases
14)Uncured bone fracture (excluding compression fracture due to osteoporosis)
15)Planned surgery
16)Obvious cavity on pulmonary lesions.
17)Bleeding tendency
18)Uncontrolled thromboembolizm
19)Pregnancy
20)Participation in the trial is judged to be inappropriate by the attending doctor
35
1st name | |
Middle name | |
Last name | Nobuyuki Katakami |
Institute of Biomedical Research and Innovation
Division of Integrated Oncology
2-2, Minatojima-minamimachi, Chuo-ku, Kobe
078-304-5200
1st name | |
Middle name | |
Last name | Akito Hata |
Institute of Biomedical Research and Innovation
Division of Integrated Oncology
2-2, Minatojima-minamimachi, Chuo-ku, Kobe
078-304-5200
a-hata@fbri.org
Hanshin Oncology Group
None
Self funding
NO
大阪府立成人病センター(大阪府)
京都桂病院(京都府)
倉敷中央病院(岡山県)
神戸市立医療センター中央市民病院(兵庫県)
神戸市立医療センター西市民病院(兵庫県)
神戸大学医学部附属病院(兵庫県)
刀根山病院(大阪府)
先端医療センター(兵庫県)
兵庫県立がんセンター(兵庫県)
2013 | Year | 09 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2012 | Year | 08 | Month | 30 | Day |
2017 | Year | 12 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010315
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