An exploratory observational study of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer
- Conditions
- non-squamous non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000009571
- Lead Sponsor
- Respiratory Center, Showa University Northern Yokohama Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Not provided
1.Uncontrolled ascites, pleural effusion,or pericardial effusion, 2.Patients with infectious disease requiring systemic administration of antiviral agents,antifungal agents,or antibiotics. 3.Patients with multiple cancers within 5years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer. 4.Patients with serious complications (such as heart disease,activity infection, interstitial pneumonia, diabetes) 5.Pregnant woman or those with suspected pregnancy,nursing woman and those who plan to become pregnant during the study period. 6.Other patients whom the investigation considers to be unsuitable for participation in the study. In case of using Bevacizumab,confirm that the patients do not come under the following, as general.However, patients are allowed to be registered to this study as for as the doctor's decision. 1.Patients with symptomatic brain metastases. 2.Patients with history or complication of hemoptysis. Definition of hemoptysis is determined by the following. A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine. 3. Patients with tumor invasion to chest great vessels. 4. Patients with obvious tumor invasion to the lobar bronchi, main bronchus or trachea. 5. Patients with obvious lung lesion hollowing(>1cm). 6. Patients come under the following on the first day of administration within a week from the last palliative radiotherapy. within 8weeks from lobectomy surgery. within 4weeks from exploratory thoracotomy. within a week from thoracic drainage. 7.Patients with uncontrolled hypertension 8.Patients receiving anticoagulant therapy Patients receiving 325mg aspirin therapy are allowed to be registered. 9.Patients with a history ofgastrointestinal perforation within an year,or a complication of uncontrollable peptic ulcer.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and safety(Response rate)
- Secondary Outcome Measures
Name Time Method Progression free survival, overall survival, adverse event, Predictive factors(characteristic, EGFR genetic mutation, hypertension)