Unique ID issued by UMIN | UMIN000030833 |
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Receipt number | R000035191 |
Scientific Title | Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab.Accompaniment research of TORG1321 study (UMIN000010681) |
Date of disclosure of the study information | 2018/01/16 |
Last modified on | 2021/11/08 11:14:40 |
Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab.Accompaniment research of TORG1321 study (UMIN000010681)
Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab(TORG1321-S).
Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab.Accompaniment research of TORG1321 study (UMIN000010681)
Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab(TORG1321-S).
Japan |
Non-squamous non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
Examination of the immunity in patients with advancer non-small cell lung cancer treated with bevacizumab. (The comparison of the immunity between patients with or without treatment of bevacizumab.)
PK,PD
Exploratory
Pragmatic
Not applicable
Examination of the immunity in patients entered TORG1321 study (UMIN000010681).
The comparison of the immunity between patients with or without treatment of bevacizumab.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 q3wks until PD
CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 BEV 15mg/kg q3wks until PD
20 | years-old | <= |
74 | years-old | >= |
Male and Female
First step(induction)
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Wild type EGFR
3)Stage IIIB,stageIV without any indications for radiotherapy
4)No prior chemotherapy
5)ECOG performance status 0-1
6)With one or more measurable disease (RECIST ver.1.1)
7) Aged 20<=, <=74
8)Adequate organ function
9)In case of non-chest radiation, need more than two weeks interval after last radiation
10)Written informed concent
Second step (maintenance)
1)Non-PD patients after induction therapy
2)Adequate organ function after non-PD confirmation
3)ECOG performance status 0-1
First step(induction)
1)Symptomatic brain metastasis
2)Current history of hemoptysis
3)With pulmonary cavity
lesions
4)History of radical thoracic radiotherapy
5)Active infections diseases
6)Fever over 38 degrees centigrade
7)Serious complications
8)Massive pleural and cardiac effusion and ascites that need to be immediately treated
9)Active concomitant cancers
10)Severe drug allergy
11)Uncontrollable ulcer indigestive tract
12)Perforation of the digestive tract or history within the past one year
13)Receiving anticoagulant drug (325mg and less aspirin is possible)
14) Pregnancy, breastfeeding or suspected of being pregnant
15)Those judged to be not suitable by the attending physician
Second step (maintenance)
1)Symptomatic brain metastasis
2)Accompanied by serious complication in induction therapy
3) Severe drug allergy for PEM or BEM or severe adverse effect in induction therapy
30
1st name | Takashi |
Middle name | |
Last name | Kasai |
Tochigi Cancer Center
Department of Medical Oncology, Division of Thoracic Oncology
320-0834
4-9-13, Yonan, Utsunomiya,Tochigi, Jaspan
+81-28-658-5151
takasai@tochigi-cc.jp
1st name | Takashi |
Middle name | |
Last name | Kasai |
Tochigi Cancer Center
Department of Medical Oncology, Division of Thoracic Oncology
320-0834
4-9-13, Yonan, Utsunomiya,Tochigi, Jaspan
+81-28-658-5151
takasai@tochigi-cc.jp
Thoracic Oncology Research Group
Thoracic Oncology Research Group
Other
Tochigi Cancer Center ethics committee
4-9-13, Yonan, Utsunomiya,Tochigi, Jaspan
+81-45-534-4112
-
NO
2018 | Year | 01 | Month | 16 | Day |
Unpublished
8
Completed
2016 | Year | 05 | Month | 31 | Day |
2016 | Year | 09 | Month | 14 | Day |
2016 | Year | 09 | Month | 15 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 12 | Month | 31 | Day |
2018 | Year | 01 | Month | 16 | Day |
2021 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035191
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