First Line Ovarian Cancer Treatment - Cohort Study (ENCOURAGE)

March 15, 2016 updated by: ARCAGY/ GINECO GROUP

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

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 ®)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Centre Paul Papin
      • Bordeaux, France
        • Institut Bergonié
      • Bordeaux, France
        • Clinique Tivoli
      • Clermont Ferrand, France
        • Centre Jean Perrin
      • Fréjus, France
        • Centre Hospitalier Intercommunal
      • Marseille, France
        • Institut Paoli Calmette
      • Nimes, France
        • Clinique Valdegour
      • Orléans, France
        • Centre Hospitalier Régional
      • Paris, France
        • ARCAGY-GINECO
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon-Sud
      • Reims, France
        • Institut Jean Godinot
      • Saint Brieuc, France
        • Clinique Armoricaine de Radiologie
      • St Herblain, France
        • ICO René Gauducheau
      • Strasbourg, France
        • Hopital Civil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Use of bevacizumab (Avastin ®) - First-line ovarian cancer
Patient receiving bevacizumab in ovarian cancer first line treatment
Drug: Bevacizumab
Observation of bevacizumab administration in first line ovarian cancer treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety according to CTCAE v4.0 criteria
Time Frame: Patient will be followed dureing 36 months
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
Time Frame: Patient will be followed during 36 months
• 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
Time Frame: Patient will be followed during 36 months
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
Time Frame: At registration
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
Time Frame: At registration
Discribe the reason why patient receive or not bevacizumab in first line of ovarian cancer treatment
At registration
Evaluation of monitoring practices of bevacizumab
Time Frame: The patients will be followed during 36 months
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
Time Frame: The patients will be followed during 36 months
Discribe how bevacizumab is administered in the daily practice
The patients will be followed during 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Dominique BERTON-RIGAUD, MD, ICO de l'Ouest, Site René Gauducheau - Saint-Herblain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENCOURAGE (GINECO-OV123)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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