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First Line Ovarian Cancer Treatment - Cohort Study (ENCOURAGE)

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ClinicalTrials.gov Identifier: NCT01832415
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
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 ®)

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer Drug: Bevacizumab

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
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 Start Date : April 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2016


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832415


Locations
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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, 69495
Institut Jean Godinot
Reims, France
Clinique Armoricaine de Radiologie
Saint Brieuc, France
ICO René Gauducheau
St Herblain, France
Hôpital Civil
Strasbourg, France
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Roche Pharma AG
Investigators
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Principal Investigator: Dominique BERTON-RIGAUD, MD ICO de l'Ouest, Site René Gauducheau - Saint-Herblain

Additional Information:

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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01832415     History of Changes
Other Study ID Numbers: ENCOURAGE (GINECO-OV123)
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by ARCAGY/ GINECO GROUP:
First line treatment
Ovarian cancer
Avastin
fallopian tube or primary peritoneal
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors