Unique ID issued by UMIN | UMIN000005764 |
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Receipt number | R000006511 |
Scientific Title | A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients |
Date of disclosure of the study information | 2011/06/16 |
Last modified on | 2014/06/13 09:10:45 |
A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Japan |
Non-squarmous Non Small Cell Lung Cancer(non-pretreated patient)
Pneumology | Chest surgery |
Malignancy
NO
To access the efficacy and safety of maintenance Bevacizumab+Pemetrexed following Platinum Doublet+Bevacizumab
Safety,Efficacy
Progression Free Survival
Safety
Overall Survival
Rate of shift to maintenance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Pulatinum doublet and Bevacizumab followed by maintenance Bevacizumab and Pemetrexed until Clinical disease progression
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Histologically or cytologically proven non small cell lung cancer(non-squarmous cell lung cancer)
2)Stage 3B/4
3)With evaluated and measured lesion according to RECIST(Ver.1.1)
4)Age 20-75
5)ECOG PS0-1
6)Adequate functions of major organs
7)Written informed concent
1)Previous hemopotysis (2.5ml)
2)Brain metastasis.
3)Any operation, biopsy associated with section, or any saturation of wounds within 4 weeks before enrollment.
4)Untreated traumatic bone fracture.
5)Consolidated or history of gastric perforation within 1 year before enrollment.
6)Uncontrollable peptic ulcer.
7)Tendency to bleed, or coagulation defect.
8)Treated with antithrombotic drugs within 10 days before enrollment.
9)Chronic inflammatory disease requiring anti-platelet agent.
10)History of interstitial lung disease.
11)Uncontrollable pleural effusion or ascites.
12)Uncontrollable heart disease and/or hypertension.
13)Cardiac infraction or cerebral infraction within 6 months before enrollment.
14)Have another active malignancy.
15)Severe infection or malnutrition.
16)Severe drug allergy.
17)In pregnancy, during breast feeding, or possibility of pregnancy.
18)Invasion to major vessel.
19)Cavitation of tumor.
20)History of chest irradiation (excluding if radiation field does not cover the primary tumor).
21)Any patient who is judged to be inappropriate for participation.
48
1st name | |
Middle name | |
Last name | Yoshinobu Iwasaki |
Kyoto Prefectural University of Medicine
Pulmonary Medicine
465 Kajii-cho, Kamigyoku, Kyoto city 602-8566
075-251-5513
yiwasaki@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Yoshinobu Iwasaki |
Kyoto Prefectural University of Medicine
Pulmonary Medicine
Hirokoji, Kawaramachi, Kamigyo-ku, Kyoto
075-251-5513
yiwasaki@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Kyoto Prefectural University of Medicine
Self funding
NO
京都府立医科大学附属病院(京都府)
2011 | Year | 06 | Month | 16 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 15 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 06 | Month | 13 | Day |
2014 | Year | 06 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006511
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