Phase II study of efficacy of Bevacizumab plus chemotherapy for malignant pleural effusion (MPE) management of treated or untreated non-squamous non-small lung cancer(NSCLC) patients with uncontrollable MPEs by pleurodesis (NEJ-013B-2)
- Conditions
- non-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000006868
- Lead Sponsor
- orth East Japan Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
1.interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2. history of gross hemoptpsis (2.5ml or more) or severe hemosputum (over 1 week, or reciveing hemostatic drug) 3. symptomatic brain metastasis 4.recieving anticoagulant drug (except Aspirin under 324mg/day) 5. scheduled operation 6. invasion to major vessels 7. pulmonary tumor with the cavity 8. severe complication 9. uncontrolled infection 10. Uncontrollable gastriointestinal ulceration 11. history of GI perforation or ulceration (within 1 year) 12.present pregnant or lactation 13. severe drug allegy 14. history of myocardial infarction or cerebral infarction (within 1 year) 15.active concomitant malignancy 16. inappropriate patients judged by the phsicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE for eight weeksfor eight weeks from the start of treatment
- Secondary Outcome Measures
Name Time Method Pleural Progression free survival(PPFS) defined as progression-free survival time (PFS) without reaccumulation of MPE, calculated from the time of starting bevacizumab-based therapy until the day on which pleural effusions increased again, or the day of death regardless of cause; Safty; QOL; Biomarker analysis