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Phase II study of Pemetrexed and Cisplatin plus Bevacizumab with Maintenance Pemetrexed as First-Line Therapy for Nonsquamous Non-small-cell Lung Cancer (ALCT001)

Phase 2
Conditions
onsquamous Non-small-cell Lung Cancer
Registration Number
JPRN-UMIN000010804
Lead Sponsor
Kyorin Univercity Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

1)active or symptomatic interstitial lung disease 2)clinically significant cardiovascular disease and DVT 3)medically uncontrolled hypertension and diabetes 4)clinically significant infectious disease 5)history of diverticulitis or clinically significant diverticular disease 6)history of gross hemoptysis (2.5ml) 7)primary tumor in close proximity to a major vessel 8)primary tumor with cavitation 9)melena 10)regular use of aspirin 11)proteinuria(Grade2) 12)history of thrombotic or hemorrhagic disorder 13)uncontrollable pleural effusion and ascites 14)symptomatic brain metastasis 15)active double cancer 16)pregnancy or lactation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary end point of this study was PFS, defined as the time from registration to the time of documented disease progression.
Secondary Outcome Measures
NameTimeMethod
Safety,Response rate,Disease control rate,OS,1-year survival rate,QO
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