Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.
It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally advanced and metastatic nsclc | non squamous |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events during 24 months of follow-up | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 24 months |
Inclusion Criteria:
Exclusion Criteria:
18. Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies 19. Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications 20. Patients diagnosed with a tracheo-esophageal fistula 21. Prior chemotherapy or treatment with another systemic anti-cancer agent 22. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent 23. History of thrombotic disorders within the last 6 months prior to enrollment.
Not provided
Not provided
Not provided
Patients with histologically or cytologically documented advanced metastatic (patients who are not candidates for radiotherapy, i.e. supraclavicular lymph node metastases or Stage IIIb with malignant pleural or pericardial effusion or Stage IV) or recurrent non-squamous non-small cell lung cancer.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kostas N Syrigos, Professor | Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Unit Sotiria Hospital of Chest Diseases | Athens | 115 27 | Greece |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |