First Line Ovarian Cancer Treatment - Cohort Study

ARCAGY/ GINECO GROUP500 enrolled

Overview

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 ®)

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

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Epithelial Ovarian Cancer

Interventions

BevacizumabDRUG

Observation of bevacizumab administration in first line ovarian cancer treatment

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Centre Paul Papin

Angers, France

Clinique Tivoli

Bordeaux, France

Institut Bergonié

Bordeaux, France

Outcomes

Primary Outcomes

Safety according to CTCAE v4.0 criteria

To assess patient safety and the tolerance of bevacizumab andministered regarding the daily practice of the oncologist.

Time frame: Patient will be followed dureing 36 months

Secondary Outcomes

Efficacy

• Evaluate the efficacy of bevacizumab (Avastin ®) in terms of progression-free survival (PFS) .

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: At registration

Evaluation of monitoring practices of bevacizumab

Discribe the method that are used during a treatment by bevacizumab in the daily practice

Time frame: 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

Time frame: The patients will be followed during 36 months

Data from ClinicalTrials.gov

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