Epithelial Ovarian Cancer
Conditions
Keywords
First line treatment, Ovarian cancer, Avastin, fallopian tube or primary peritoneal
Brief summary
The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of bevacizumab (Avastin ®)
Detailed description
Population: Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal or witch it was decided to initiate a process comprising of Bevacizumab (Avastin ®) in first-line therapy
Interventions
DRUGBevacizumab
Observation of bevacizumab administration in first line ovarian cancer treatment
Sponsors
Roche Pharma AG
ARCAGY/ GINECO GROUP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and over, * Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive bevacizumab (Avastin ®) in first-line therapy * Patients should be informed of the study orally and should not have any objection their data to be processed.
Exclusion criteria
* Patient participation in a clinical trial * Patient non-affiliated to a social security scheme.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety according to CTCAE v4.0 criteria | Patient will be followed dureing 36 months | To assess patient safety and the tolerance of bevacizumab andministered regarding the daily practice of the oncologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment at relapse | Patient will be followed during 36 months | Evaluate the efficacy of the treatment that will be administered at the disease relapse. |
| Characteristics of the population registered | At registration | Discribe the population that will be registered to make correlation with the safety and efficacy measure |
| Efficacy | Patient will be followed during 36 months | • Evaluate the efficacy of bevacizumab (Avastin ®) in terms of progression-free survival (PFS) . |
| Evaluation of monitoring practices of bevacizumab | The patients will be followed during 36 months | Discribe the method that are used during a treatment by bevacizumab in the daily practice |
| Evaluation of the modality of use of bevacizumab | The patients will be followed during 36 months | Discribe how bevacizumab is administered in the daily practice |
| Indication and cons indication of bevacizumab in clinical practice | At registration | Discribe the reason why patient receive or not bevacizumab in first line of ovarian cancer treatment |
Countries
France
Outcome results
None listed