First Line Ovarian Cancer Treatment - Cohort Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Non Interventional Study Dealing With the Use of Bevacizumab (Avastin®) in Patients With Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal and Treated in First-line Therapy

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Use of bevacizumab (Avastin ®) - First-line ovarian cancer<br>Patient receiving bevacizumab in ovarian cancer first line treatment | Drug: Bevacizumab<br>* Observation of bevacizumab administration in first line ovarian cancer treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety according to CTCAE v4.0 criteria | To assess patient safety and the tolerance of bevacizumab andministered regarding the daily practice of the oncologist. | Patient will be followed dureing 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | • Evaluate the efficacy of bevacizumab (Avastin ®) in terms of progression-free survival (PFS) . | Patient will be followed during 36 months | 
| Efficacy of treatment at relapse | Evaluate the efficacy of the treatment that will be administered at the disease relapse. | Patient will be followed during 36 months | 
| Characteristics of the population registered | Discribe the population that will be registered to make correlation with the safety and efficacy measure | At registration | 
| Indication and cons indication of bevacizumab in clinical practice | Discribe the reason why patient receive or not bevacizumab in first line of ovarian cancer treatment | At registration | 
| Evaluation of monitoring practices of bevacizumab | Discribe the method that are used during a treatment by bevacizumab in the daily practice | The patients will be followed during 36 months | 
| Evaluation of the modality of use of bevacizumab | Discribe how bevacizumab is administered in the daily practice | The patients will be followed during 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First line treatment, Ovarian cancer, Avastin, fallopian tube or primary peritoneal