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Completed

NCT Number: NCT01832415

First Line Ovarian Cancer Treatment - Cohort Study

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 ®)

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Paul Papin, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

Observation of bevacizumab administration in first line ovarian cancer treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. Efficacy

    Time frame: Patient will be followed during 36 months

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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study 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

Acronym: ENCOURAGE

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 16, 2013
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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