A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
- Conditions
- Previously treated non-small cell lung cancer
- Registration Number
- JPRN-UMIN000008158
- Lead Sponsor
- Dept. of Respiratory Medicine, Osaka University Hospital
- Brief Summary
Thirty patients were enrolled. The RR was 6.7% (95%CI 1.8-21.3%), and the disease control rate was 80% (95%CI 62.7-90.5%). Median PFS was 4.8 months (95%CI 2.7-6.4 months), and median OS was 13.8 months (95%CI 8.4 months-not applicable). Patients did not experience any Grade 4 toxicity or treatment-related death. Grade 3 hematologic toxicity (anemia) occurred in one patient (3.3%). The main Grade 3 non-hematologic toxicities were anorexia (10%), infection (10%), and diarrhea (6.7%).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1.Adjuvant chemotherapy 2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia. 3.History of severe drug allergy 4.Active synchronous malignancies 5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 6.Severe complication 7.Metastasis to CNS 8.Patients with chest radiation treatment is required to reach the lung irradiation 9.Treated by flucytosine (5-FC) 10.Symptomatic brain metastasis 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, Overall survival, Frequency and grade of adverse event