Clinical trial NCT01832415: First Line Ovarian Cancer Treatment - Cohort Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Keywords: First line treatment
Ovarian cancer
Avastin
fallopian tube or primary peritoneal
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2013-04-16
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving Bevacizumab (Avastin ®) in first-line therapy

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

Eligibility criteria: 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.

Primary outcomes:
measure: Safety according to CTCAE v4.0 criteria
timeFrame: Patient will be followed dureing 36 months
Secondary outcomes:
measure: Efficacy
timeFrame: Patient will be followed during 36 months
measure: Efficacy of treatment at relapse
timeFrame: Patient will be followed during 36 months
measure: Characteristics of the population registered
timeFrame: At registration
measure: Indication and cons indication of bevacizumab in clinical practice
timeFrame: At registration
measure: Evaluation of monitoring practices of bevacizumab
timeFrame: The patients will be followed during 36 months
measure: Evaluation of the modality of use of bevacizumab
timeFrame: The patients will be followed during 36 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont Ferrand
country: France
facility: Centre jean Perrin
city: Fréjus
country: France
facility: Centre Hospitalier Intercommunal
city: Marseille
country: France
facility: institut Paoli Calmette
city: Nimes
country: France
facility: Clinique Valdegour
city: Orléans
country: France
facility: Centre Hospitalier Régional
city: Paris
country: France
facility: Arcagy-Gineco
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: St Herblain
country: France
facility: ICO René Gauducheau
city: Strasbourg
country: France
facility: Hôpital Civil
Study officials:
affiliation: ICO de l'Ouest, Site René Gauducheau - Saint-Herblain
name: Dominique BERTON-RIGAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berton D, Floquet A, Lescaut W, Baron G, Kaminsky MC, Toussaint P, Largillier R, Savoye AM, Alexandre J, Delbaldo C, Malaurie E, Barletta H, Bosacki C, Garnier-Tixidre C, Follana P, Laharie-Mineur H, Briac Levache C, Valenza B, Dechartres A, Mollon-Grange D, Selle F. Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients. Front Pharmacol. 2021 Sep 20;12:711813. doi: 10.3389/fphar.2021.711813. eCollection 2021.