FRESH-PEF74115-en
A cohort study of patients with advanced, unresectable (stage IIIB) metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) or in relapse starting treatment with Avastin® in combination with chemotherapy as first line treatment of metastatic disease
EOLE
| Name |
|---|
| France |
This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice 1. To describe characteristics of patients treated with Avastin®: demographic and clinical characteristics, history of the disease, and previous disorders and conditions, 2. To describe methods of use of Avastin® in follow-up: doses and durations of treatment with Avastin® (number of cycles); chemotherapy treatments used in combination with treatment with Avastin®; discontinuation of treatment with Avastin® (temporary and permanent) and reasons; treatment strategies set up after discontinuation of treatment with Avastin®, 3. To describe overall survival of patients treated with Avastin®, 4. To describe the safety profile of treatment with Avastin®: serious and non-serious adverse events and targeted adverse events, 5. To describe quality of life: Spitzer's quality of life questionnaire, 6. To describe therapeutic management of patients with non-squamous cell NSCLC in first-line chemotherapy of metastatic disease not receiving Avastin®: compilation of an anonymous registry over a 3-month period starting with time of scientific set up by the investigator.
['Clinical data']
Individuals
| Topic | Vocabulary | URI |
|---|---|---|
| Oncology | health theme | |
| cim-11 | http://id.who.int/icd/entity/1331250723 | |
| Healthcare system determinants: Use of care | health determinant | |
| Healthcare system determinants | health determinant |
{
"level_sex_clusion_I": [
"Male",
"Female"
],
"level_age_clusion_I": [
"Young Adult (19 to 24 years)",
"Adult (25 to 44 years)",
"Middle Aged (45 to 64 years)",
"Aged (65 to 79 years)",
"Aged, 80 and over (80 years and more)"
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "",
"clusion_E": ""
}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Autre |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['Other']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2011 | 2013 |
Longitudinal or cohort study
GCP/GVP
Restricted access
| Name | |
|---|---|
| Medical data center | data_sharing.france@roche.com |
FRESH-PEF74115-en