NCT01832415

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 ®)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 28, 2013

Last Update Submit

March 15, 2016

Conditions

Epithelial Ovarian Cancer

Keywords

First line treatmentOvarian cancerAvastinfallopian tube or primary peritoneal

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Efficacy

    Patient will be followed during 36 months

  • Efficacy of treatment at relapse

    Patient will be followed during 36 months

  • Characteristics of the population registered

    At registration

  • Indication and cons indication of bevacizumab in clinical practice

    At registration

  • Evaluation of monitoring practices of bevacizumab

    The patients will be followed during 36 months

  • +1 more secondary outcomes

Study Arms (1)

Use of bevacizumab (Avastin ®) - First-line ovarian cancer

Patient receiving bevacizumab in ovarian cancer first line treatment

Drug: Bevacizumab

Interventions

BevacizumabDRUG

Observation of bevacizumab administration in first line ovarian cancer treatment

Use of bevacizumab (Avastin ®) - First-line ovarian cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

• Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving Bevacizumab (Avastin ®) in first-line therapy

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Centre Paul Papin

Angers, France

Location

Clinique Tivoli

Bordeaux, France

Location

Institut Bergonié

Bordeaux, France

Location

Centre jean Perrin

Clermont-Ferrand, France

Location

Centre Hospitalier Intercommunal

Fréjus, France

Location

institut Paoli Calmette

Marseille, France

Location

Clinique Valdegour

Nîmes, France

Location

Centre Hospitalier Régional

Orléans, France

Location

Arcagy-Gineco

Paris, France

Location

Centre Hospitalier Lyon-sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, France

Location

ICO René Gauducheau

Saint-Herblain, France

Location

Hôpital Civil

Strasbourg, France

Location

Related Publications (1)

  • Berton D, Floquet A, Lescaut W, Baron G, Kaminsky MC, Toussaint P, Largillier R, Savoye AM, Alexandre J, Delbaldo C, Malaurie E, Barletta H, Bosacki C, Garnier-Tixidre C, Follana P, Laharie-Mineur H, Briac Levache C, Valenza B, Dechartres A, Mollon-Grange D, Selle F. Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients. Front Pharmacol. 2021 Sep 20;12:711813. doi: 10.3389/fphar.2021.711813. eCollection 2021.

    PMID: 34616296DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialOvarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Dominique BERTON-RIGAUD, MD

    ICO de l'Ouest, Site René Gauducheau - Saint-Herblain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 16, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2015

Study Completion

March 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

FR(14)