Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly Participants with Ovarian Cancer | Elderly participants aged 70 years and older administered frontline treatment for International Federation for Gynecology and Obstetrics (FIGO) stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be prescribed by the local clinician according to the SmPC and standard of care for up to 15 months. No treatment will be provided by the Sponsor in this non-interventional study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Per routine clinical practice during bevacizumab treatment (up to 15 months) | |
| Time to First Incidence of Adverse Events of Special Interest | Per routine clinical practice during bevacizumab treatment (up to 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) | Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall) | |
| Percentage of Participants with Complete or Partial Response According to RECIST |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Real-world patients (70 years of age and older) with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are receiving frontline treatment with bevacizumab and chemotherapy according to standard of care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| AZ Sint Lucas Brugge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35063943 | Derived | Vergote I, Van Nieuwenhuysen E, De Waele S, Vulsteke C, Lamot C, Van den Bulck H, Claes N, Graas MP, Debrock G, Spoormans I, Vuylsteke P, Honhon B, Verhoeven D, De Maeseneer D, Dirix L, Mebis J, Vroman P, Denys H, Martinez Mena C, Pelgrims G, Van Steenberghe M, van Gorp T, Gennigens C. Prospective non-interventional BELOVA/BGOG-ov16 study on safety of frontline bevacizumab in elderly patients with FIGO stage IV ovarian cancer: a study of the Belgian and Luxembourg Gynaecological Oncology Group. Int J Gynecol Cancer. 2022 Jun 6;32(6):753-760. doi: 10.1136/ijgc-2021-003190. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Carboplatin | Drug | Carboplatin will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study. |
|
| Paclitaxel | Drug | Paclitaxel will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study. |
|
| Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall) |
| Overall Survival | Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall) |
| Comprehensive Geriatric Assessment Subscale Scores | Baseline, end of chemotherapy (up to 18 weeks), and after 10 and 15 months of bevacizumab treatment or at disease progression (up to 15 months overall) |
| Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg) | Every 3 weeks according to SmPC for up to 15 months |
| Total Number of Bevacizumab Doses | Every 3 weeks according to SmPC for up to 15 months |
| Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab | Every 3 weeks per routine clinical practice for up to 18 weeks |
| Assebroek |
| 8310 |
| Belgium |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| AZ KLINA | Brasschaat | 2930 | Belgium |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| CHU St Pierre (St Pierre) | Brussels | 1000 | Belgium |
| Cliniques Uni Ires Saint-Luc; Gynaecology | Brussels | 1200 | Belgium |
| GHdC Site Notre Dame | Charleroi | 6000 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| ZOL (Sint Jan) | Genk | 3600 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| AZ Sint Lucas (Sint Lucas) | Ghent | 9000 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| CH Jolimont - Lobbes (Jolimont) | Haine-Saint-Paul | 7100 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Chr de La Citadelle | Liège | 4000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Clinique Saint-Joseph | Liège | 4000 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| AZ Damiaan | Ostend | 8400 | Belgium |
| AZ Nikolaas (Sint Niklaas) | Sint-Niklaas | 9100 | Belgium |
| AZ Turnhout Sint Elisabeth | Turnhout | 2300 | Belgium |
| CHR de Verviers - East Belgium | Verviers | 4800 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided