Unique ID issued by UMIN | UMIN000007475 |
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Receipt number | R000008808 |
Scientific Title | A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab. North Japan Lung Cancer Study Group Trial 1201 |
Date of disclosure of the study information | 2012/03/09 |
Last modified on | 2014/09/09 11:51:33 |
A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab.
North Japan Lung Cancer Study Group Trial 1201
Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)
A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab.
North Japan Lung Cancer Study Group Trial 1201
Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)
Japan |
non-squamous non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate and compare the efficacy and safety of combination of bevacizumab and erlotinib versus erlotinib monothearpy in NSCLC patients who were previously treated with bevacizumab containing rejimen.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Progression Free Survival at 3 months after randomized
Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival, Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Erlotinib
Erlotinib + Bevacizumab
20 | years-old | <= |
Not applicable |
Male and Female
1)stage IIIB/IV or recurrence and histologically or cytologically confirmed non-squamous non-small lung cancer
2)history of 2 courses or more bevacizumab plus platinum doublet
3)known no active EGFR gene mutation
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*palliative radiotherapy(ex thorax):2weeks
*operation:4 weeks
*chest drainage:1weeks
*biopsy with incision, port custody,and treatment to injury:2weeks
8)adequate bone marrow,liver,and renal functions
9)a life expectancy of 3 months or more
10)written informed consent
1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known active EGFR gene mutation
3)history of erlotinib or gefitinib treatment
4)inable of oral drug administration
5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC
6)Risk of hemoptysis patients after thoracic radiation therapy is expected
7)With great vessel invasion
8)1cm or longer cavity in tumor
9)current or previous (within the last 1 year)history of GI perforation
10)history of myocardial infarction and cerebral infarction
11)planned surgery within study term
12)uncontrolled heypertension
13)symptomatic brain metastasis
14)history of drug allergy
15)massive,pleural effusion or ascites
16)uncontrolled infection or serious medical complications
17)active concomitant malignancy
18)mental disorder
19)pregnant or or lactating women or those who declined contraception
20)those judged not suitable by the attending physician
64
1st name | |
Middle name | |
Last name | Shunichi Sugawara |
Sendai Kousei Hospital
Department of Respiratory Medicine
4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
022-222-6181
swara357@cat-v.ne.jp
1st name | |
Middle name | |
Last name | Shunichi Sugawara |
Sendai Kousei Hospital
Department of Respiratory Medicine
4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
022-222-6181
swara357@cat-v.ne.jp
North Japan Lung Cancer Study Group
None
Self funding
YES
NJLCG1201
North Japan Lung Cancer Study Group
2012 | Year | 03 | Month | 09 | Day |
Unpublished
Terminated
2012 | Year | 02 | Month | 16 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 09 | Day |
2014 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008808
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