First Line Ovarian Cancer Treatment - Cohort Study

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01832415
• Lead Sponsor: ARCAGY/ GINECO GROUP

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

Study Timeline

• Study First Submitted: 2013-03-28
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Primary Completion: 2015-02
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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.

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Exclusion Criteria

• Patient participation in a clinical trial
• Patient non-affiliated to a social security scheme.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Use of bevacizumab (Avastin ®) - First-line ovarian cancer	Bevacizumab	Patient receiving bevacizumab in ovarian cancer first line treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Efficacy	Patient will be followed during 36 months	• Evaluate the efficacy of bevacizumab (Avastin ®) in terms of progression-free survival (PFS) .
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
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
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

Trial Locations

Locations (14)

Hôpital Civil; 🇫🇷 Strasbourg, France

Arcagy-Gineco; 🇫🇷 Paris, France

Centre Hospitalier Régional; 🇫🇷 Orléans, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre jean Perrin; 🇫🇷 Clermont Ferrand, France

Clinique Armoricaine de Radiologie; 🇫🇷 Saint Brieuc, France

ICO René Gauducheau; 🇫🇷 St Herblain, France

Centre Hospitalier Lyon-sud; 🇫🇷 Pierre-Bénite, France

institut Paoli Calmette; 🇫🇷 Marseille, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier Intercommunal; 🇫🇷 Fréjus, France

Clinique Valdegour; 🇫🇷 Nimes, France