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A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer Previously Treated with Platinum based Chemotherapy

Phase 2
Conditions
on-Squamous Non-Small-Cell Lung Cancer
Registration Number
JPRN-UMIN000003533
Lead Sponsor
Hanshin Cancer Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
90
Inclusion Criteria

Not provided

Exclusion Criteria

1)interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)history of drug induced interstitial pneumonia 3)history of severe drug allergy 4)patients previously treated with S-1 and docetaxel. 5)history of active infection or other serious disease condition 6)history of poorly controlled pleural effusion,pericardial effusion and ascites 7)history of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,heart failure, etc.) 8)uncontrollable hypertension 9)uncontrollable diabetes mellitus 10)curative radiotherapy pretreated to the chest. 11)current history of hemosputum 12)current or previous history hemoptysis 13)current or previous (within the last 1 year) history of cerebrovascular disease 14)current or previous (within the last 1 year) history of GI perforation 15)symptomatic brain metastasis 16)traumatic fracture of unrecovery 17)the operation has been scheduled for the examination period 18)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor 19)evidence of bleeding diathesis or coagulopathy 20)thrombosis that need to treat 21)severe drug allergy for 80 polysorbate content medicine 22)patients using Flucytosine 23)patients with contraindication of medication (DTX,S-1). 24)history of active double cancer 25)history of active psychological disease 26)history of pregnancy or lactation 27)any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression free survival
Secondary Outcome Measures
NameTimeMethod
Response rate Overall survival Disease control rate Rate of adverse events
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