First Line Ovarian Cancer Treatment - Cohort Study

Epithelial Ovarian Cancer Clinical Trial

— ENCOURAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832415
• Other study ID #: ENCOURAGE (GINECO-OV123)
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: March 15, 2016
• Start date: April 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The National Commission for Informatics and Liberties (CNIL in french)
• Study type: Observational [Patient Registry]

Clinical Trial 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 ®)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab
Observation of bevacizumab administration in first line ovarian cancer treatment

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Clinique Tivoli	Bordeaux
France	Institut Bergonié	Bordeaux
France	Centre jean Perrin	Clermont Ferrand
France	Centre Hospitalier Intercommunal	Fréjus
France	institut Paoli Calmette	Marseille
France	Clinique Valdegour	Nimes
France	Centre Hospitalier Régional	Orléans
France	Arcagy-Gineco	Paris
France	Centre Hospitalier Lyon-sud	Pierre-Bénite
France	Institut Jean Godinot	Reims
France	Clinique Armoricaine de Radiologie	Saint Brieuc
France	ICO René Gauducheau	St Herblain
France	Hôpital Civil	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Efficacy	• Evaluate the efficacy of bevacizumab (Avastin ®) in terms of progression-free survival (PFS) .	Patient will be followed during 36 months	No
Secondary	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	No
Secondary	Characteristics of the population registered	Discribe the population that will be registered to make correlation with the safety and efficacy measure	At registration	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No