Epithelial Ovarian CancerENCOURAGENCT01832415
First Line Ovarian Cancer Treatment - Cohort Study
An observational study of Epithelial Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 14 sites in France.
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 ®) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Bevacizumab
- How many people
- 500 participants
- Where
- 14 sitesFrance
- Study dates
- Apr 2013to Mar 2016
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: • Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving Bevacizumab (Avastin ®) in first-line therapy
Who may be able to join
- 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.
Who cannot join
- Patient participation in a clinical trial
- Patient non-affiliated to a social security scheme.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Centre Paul Papin
Angers
Clinique Tivoli
Bordeaux
Institut Bergonié
Bordeaux
Centre jean Perrin
Clermont-Ferrand
Centre Hospitalier Intercommunal
Fréjus
institut Paoli Calmette
Marseille
Clinique Valdegour
Nîmes
Centre Hospitalier Régional
Orléans
Arcagy-Gineco
Paris
Centre Hospitalier Lyon-sud
Pierre-Bénite, 69495
Institut Jean Godinot
Reims
Clinique Armoricaine de Radiologie
Saint-Brieuc
ICO René Gauducheau
Saint-Herblain
Hôpital Civil
Strasbourg
About this study
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
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 ®)
Read the 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
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Bevacizumab
- Keywords
- First line treatment, Ovarian cancer, Avastin, fallopian tube or primary peritoneal
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Observation of bevacizumab administration in first line ovarian cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| Use of bevacizumab (Avastin ®) - First-line ovarian cancer | Patient receiving bevacizumab in ovarian cancer first line treatment Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety according to CTCAE v4.0 criteria
To assess patient safety and the tolerance of bevacizumab andministered regarding the daily practice of the oncologist.
Measured: Patient will be followed dureing 36 months
Secondary outcomes (6)
Efficacy
- Evaluate the efficacy of bevacizumab (Avastin ®) in terms of progression-free survival (PFS) .
Measured: Patient will be followed during 36 months
Efficacy of treatment at relapse
Evaluate the efficacy of the treatment that will be administered at the disease relapse.
Measured: Patient will be followed during 36 months
Characteristics of the population registered
Discribe the population that will be registered to make correlation with the safety and efficacy measure
Measured: At registration
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
Measured: At registration
Evaluation of monitoring practices of bevacizumab
Discribe the method that are used during a treatment by bevacizumab in the daily practice
Measured: The patients will be followed during 36 months
Evaluation of the modality of use of bevacizumab
Discribe how bevacizumab is administered in the daily practice
Measured: The patients will be followed during 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Dominique BERTON-RIGAUD, MD, Principal investigator, ICO de l'Ouest, Site René Gauducheau - Saint-Herblain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832415
- Sponsor's protocol ID
- ENCOURAGE (GINECO-OV123)
- Acronym
- ENCOURAGE
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2013
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34616296
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01832415
- Acronym / sponsor ID
- ENCOURAGE / ENCOURAGE (GINECO-OV123)
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- First line treatment, Ovarian cancer, Avastin, fallopian tube or primary peritoneal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ®)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of bevacizumab (Avastin ®) - First-line ovarian cancer | – | Drug: BevacizumabPatient receiving bevacizumab in ovarian cancer first line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- • Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving Bevacizumab (Avastin ®) in first-line therapy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient participation in a clinical trial
- Patient non-affiliated to a social security scheme.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabObservation of bevacizumab administration in first line ovarian cancer treatment | Drug | Use of bevacizumab (Avastin ®) - First-line ovarian cancer |
Primary outcome
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.
6 secondary outcomes
Efficacy
Time frame: Patient will be followed during 36 months
Efficacy of treatment at relapse
Time frame: Patient will be followed during 36 months
Characteristics of the population registered
Time frame: At registration
Indication and cons indication of bevacizumab in clinical practice
Time frame: At registration
Evaluation of monitoring practices of bevacizumab
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 34616296Berton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique BERTON-RIGAUD, MD principal investigator
ICO de l'Ouest, Site René Gauducheau - Saint-Herblain
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety according to CTCAE v4.0 criteria (time frame: Patient will be followed dureing 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.