Unique ID issued by UMIN | UMIN000012786 |
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Receipt number | R000014925 |
Scientific Title | Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab for elderly non-squamous non-small-cell lung cancer. (TORG1323) |
Date of disclosure of the study information | 2014/01/11 |
Last modified on | 2020/04/21 13:56:19 |
Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab
for elderly non-squamous non-small-cell lung cancer. (TORG1323)
Randomized phase II study of DOC + BEV or PM +BEV for elderly non-squamous NSCLC. (TORG1323)
Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab
for elderly non-squamous non-small-cell lung cancer. (TORG1323)
Randomized phase II study of DOC + BEV or PM +BEV for elderly non-squamous NSCLC. (TORG1323)
Japan |
Advanced non-squamous non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of docetaxel+bevacizumab or pemetrexed+bevacizumab for previously untreated elderly non-squamous non-small-cell lung cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival (central review)
Safety
Progression-free survival ( attending investigator's assessment)
Response rate(RR)
Overall survival(OS)
Time to treatment failure
QOL
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
docetaxel + bevacizumab
pemetrexed + bevacizumab
75 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
2)Clinical stage IIIB(not amenable to curative radiation),VI or recurrent disease
3)ECOG performance status 0-1
4)Patients who have at least one or more measurable lesion by RESIST(Version1.1)
5)Aged 75<=
6)Adequate organ funcution
7)Interval
(1)Radiation therapy
More than 2 weeks after the last radiation therapy for nonthoracic region or brainmetastasis resion
(2)Operation
More than 4 weeks after the last operation
More than 2 weeks after the last pleurodesis or thoracic cavity drainage.
More than 8 weeks after the last operation with brain metastasis
8)Estimated life expectancy at least 12 weeks
9)Written informed consent
1)History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL within 12 weeks prior to registration
2)Symptomatic brain metastasis
3)Current or recent(within 10 days prior to first dose of bevacizumab) use of aspirin(>325mg/day), clopidogrel(>75mg/day), or current or recent(within 10 days prior to first dose of bevacizumab) use of anticlotting drug or thrombolytic agent
4)hypertension(blood pressure systolic>150mmHg and/ or diastolic >100mmHg) with or without treatment
5)Active double malignancies
6)Radiotherapy to lung field or mediastinum
7)Evidence of tumor invading a perihilar blood vessel on imaging
8)Evidence of tumor invading segmental bronchus or subsegmental bronchus on bronchofiberscopy
9)Having a history or serious complications
10)Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration
11)Psychotic disorder
12)Uncontrolled ascites, pleural effusion or cardiac effushion
13)Double cancer less than 5 years disease free period
14)Severe drug allergy
15)ctive hepatic diseases
16)A past hypersensitive for polysorbate
120
1st name | |
Middle name | |
Last name | Tetsu Shinkai |
Shonan east general hospital
Cancer center
500, Nishikubo, Chigasaki, Kanagawa
0467-83-9111
teshinkai@gmail.com
1st name | |
Middle name | |
Last name | Naoyuki Nogami, Toshiyuki Kozuki |
National Hospital Organization Shikoku Cancer Center
Department of thoracic oncology
160 Kou Minamiumemoto-machi, Matsuyama, Ehime 791-0280
089-999-1111
nnogami@shikoku-cc.go.jp
Thoracic Oncology Research Group
CHUGAI PHARMACUTICAL CO., LTD.
Profit organization
Japan
NO
2014 | Year | 01 | Month | 11 | Day |
-
Published
http://tlcr.amegroups.com/article/view/38238
103
Overall, 103 patients (DB: n=51; PB: n=52) were enrolled. In the DB and PB arms, median ages were 78 and 79 years, respectively; median PFS were 6.1 and 4.6 months, respectively [HR, 1.03; 95% CI, 0.66-1.61]; and response rates were 43%, and 40%. Grade >=3 leukopenia, neutropenia, and fatigue incidences were significantly higher in the DB arm. Febrile neutropenia incidence did not differ significantly. QoL analysis revealed less deterioration in the PB arm.
2020 | Year | 04 | Month | 21 | Day |
-
-
-
-
Completed
2013 | Year | 12 | Month | 19 | Day |
2014 | Year | 02 | Month | 17 | Day |
2014 | Year | 02 | Month | 03 | Day |
2017 | Year | 09 | Month | 30 | Day |
2017 | Year | 11 | Month | 30 | Day |
2018 | Year | 03 | Month | 31 | Day |
2014 | Year | 01 | Month | 08 | Day |
2020 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014925
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