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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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 ®)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of bevacizumab (Avastin ®) - First-line ovarian cancer | Patient receiving bevacizumab in ovarian cancer first line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Observation of bevacizumab administration in first line ovarian cancer treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | • 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 | Evaluate the efficacy of the treatment that will be administered at the disease relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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• Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving Bevacizumab (Avastin ®) in first-line therapy
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| Name | Affiliation | Role |
|---|---|---|
| Dominique BERTON-RIGAUD, MD | ICO de l'Ouest, Site René Gauducheau - Saint-Herblain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | France | ||||
| Clinique Tivoli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34616296 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 | 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 | At registration |
| Evaluation of monitoring practices of bevacizumab | 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 | Discribe how bevacizumab is administered in the daily practice | The patients will be followed during 36 months |
| Bordeaux |
| France |
| Institut Bergonié | Bordeaux | France |
| Centre jean Perrin | Clermont-Ferrand | France |
| Centre Hospitalier Intercommunal | Fréjus | France |
| institut Paoli Calmette | Marseille | France |
| Clinique Valdegour | Nîmes | France |
| Centre Hospitalier Régional | Orléans | France |
| Arcagy-Gineco | Paris | France |
| Centre Hospitalier Lyon-sud | Pierre-Bénite | 69495 | France |
| Institut Jean Godinot | Reims | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | France |
| ICO René Gauducheau | Saint-Herblain | France |
| Hôpital Civil | Strasbourg | France |
| D004701 |
| Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |